CAREERS AT AMAREX 

We are an equal opportunity employer, offering competitive salaries and excellent benefits. Amarex is currently searching for dedicated and talented individuals for the following positions: 

SENIOR PROJECT MANAGER

Position Summary:

The Sr. Project Manager is the primary point of contact for the client and is responsible for facilitating integrated project delivery, oversight, and project management of all phases of project life cycle. The Sr. Project Manager’s goal is to ensure optimal project performance including overseeing project scope, managing resource utilization, meeting key timelines and milestones, complying with quality and compliance standards, and achieving high level of client satisfaction.

Responsibilities:

  • Overall project management from project kick-off through Clinical Study Report (CSR) completion and FDA/other regulatory submission, ensuring that the project objectives have been met

  • Direct the conduct of assigned projects and activities associated with the project

  • Ensure compliance with FDA regulations, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), and Standard Operating Procedures (SOPs) for projects filed under a U.S. Investigational New Drug (IND), Investigational Device Exemption (IDE) or other FDA requirements

  • Communicate effectively with internal and external members of senior management, the project team, investigators and site personnel, and expert physicians

  • Lead the development, implementation and review of the Project-Specific Plans

  • Manage resource and financial aspects of the clinical study

  • Manage problem identification and resolution in order to adhere to the project timelines and budget

  • Recommend outsourcing when appropriate and interact with appropriate project team members to ensure that outsourcing to Contract Research Organizations (CROs)/vendors will meet expected performance standards for quality, timeliness and budget

  • Supervise the planning and facilitation of investigator meetings

  • Review recruitment strategy for meeting target enrollment of clinical protocols against target project goals

  • Develop a working knowledge of assigned protocols

  • Design, write, and review draft protocols, draft Case Report Forms (CRFs), Informed Consent Forms (ICFs), operations manuals and other documentation required for conduct of a project

  • Resolve issues regarding grant negotiations, budgets and contracts with investigational sites

  • Oversee the review of Clinical Research Associate (CRA) visit reports to assure report adequacy and adherence to project-specific monitoring plans, applicable SOPs and FDA regulations and guidelines

  • Review and approve expense reports for CRA visits

  • Review and comment on draft analysis outputs (tables, listings, and graphs) to be incorporated into CSRs, integrated summaries and New Drug Applications (NDAs)

  • Write drafts and/or review appropriate sections of the CSR

  • Work with Data Management staff to review CRF data, and interface with study personnel to resolve data queries

  • Conduct site visits for co-monitoring and auditing, as needed

  • Assume certain duties of other team members in order to meet project goals

  • Participate in interactions/meetings with regulatory authorities, as needed

  • Assist with IND and NDA coordination and preparation

  • Participate in bid defense presentations and meetings

  • Collaborate interdepartmentally on the proposal development procesS

  • Participate in the periodic review and revision of departmental policies and SOPs

  • Other duties as assigned

Required Education and Experience:

  • Bachelor’s degree (or equivalent) in life science, biological science, clinical research or any other healthcare field and 5 years experience as a clinical research professional with a CRO, pharmaceutical or biotechnology firm;
    OR
    Master’s degree (or other advanced degrees, e.g. MD, PharmD, PhD, etc.) in life science, biological science, clinical research or any other healthcare field and 3 years of experience as a clinical research professional with a CRO, pharmaceutical or biotechnology firm

  • Certification as clinical research professional (ACRP or SOCRA) is preferred.

  • Working knowledge of ICH-GCP guidelines and FDA regulations

  • Extensive understanding of clinical research principles and processes

  • Ability to apply working knowledge of clinical trial operations to manage overall project scope, budget and timelines

  • Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners

  • Dynamic individual with ability to lead and motivate team members

  • Strong verbal and written communication skills

  • Ability to work effectively both independently and in a team environment

  • Strong organizational and planning skillS

  • Excellent interpersonal and professional skills

  • Excellent time management skills with the ability to prioritize responsibilities and multitask

  • Self motivated and detail oriented

  • Ability and willingness to travel for work purposes (domestic and international)

  • Proficient in Microsoft Office and able to learn appropriate software

 

QUALITY ASSURANCE ASSISTANT

Position Summary:

The Quality Assurance (QA) Assistant provides support to the Quality Assurance department.

Responsibilities:

  • Tracking QA project timelines

  • Assisting with scheduling of internal and external meetings and audits. Preparing and distributing audit/meeting agendas and minutes

  • Maintenance of employee training files

  • Maintaining QA department files

  • Attending training sessions for all departments

  • Other general administrative support duties as assigned

Required Education and Experience:

  • Bachelor’s degree (biotechnology field preferred)

  • One year of relevant experience preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience) is preferred

  • Strong verbal and written communication skills

  • Ability to work effectively both independently and in a team environment

  • Strong organizational and professional skills

  • Effective interpersonal and professional skills

  • Excellent time management skills with the ability to prioritize responsibilities and multitask

  • Strong administrative skills

  • Excellent documentation and file management skills

  • Self-motivated and detail-oriented with excellent follow-up skills

  • Proficient in Microsoft Office and able to learn appropriate software

 

PROJECT MANAGER

Position Summary:

The Project Manager is the primary point of contact for the client and is responsible for facilitating integrated project delivery, oversight, and project management of all phases of project life cycle. The Project Manager’s goal is to ensure optimal project performance including overseeing project scope, managing resource utilization, meeting key timelines and milestones, complying with quality and compliance standards, and achieving high level of client satisfaction.

Responsibilities:

  • Overall project management from project kick-off through Clinical Study Report (CSR) completion and FDA/other regulatory submission, ensuring that the project objectives have been met

  • Direct the conduct of assigned projects and activities associated with the project

  • Ensure compliance with FDA regulations, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), and Standard Operating Procedures (SOPs) for projects filed under a U.S. Investigational New Drug (IND), Investigational Device Exemption (IDE) or other FDA requirements

  • Communicate effectively with internal and external members of senior management, the project team, investigators and site personnel, and expert physicians

  • Lead the development, implementation and review of the Project-Specific Plans

  • Manage resource and financial aspects of the clinical study

  • Manage problem identification and resolution in order to adhere to the project timelines and budget

  • Recommend outsourcing when appropriate and interact with appropriate project team members to ensure that outsourcing to Contract Research Organizations (CROs)/vendors will meet expected performance standards for quality, timeliness and budget

  • Supervise the planning and facilitation of investigator meetings

  • Review recruitment strategy for meeting target enrollment of clinical protocols against target project goals

  • Develop a working knowledge of assigned protocols

  • Design, write, and review draft protocols, draft Case Report Forms (CRFs), Informed Consent Forms (ICFs), operations manuals and other documentation required for conduct of a project

  • Resolve issues regarding grant negotiations, budgets and contracts with investigational sites

  • Oversee the review of Clinical Research Associate (CRA) visit reports to assure report adequacy and adherence to project-specific monitoring plans, applicable SOPs and FDA regulations and guidelines

  • Review and approve expense reports for CRA visits

  • Review and comment on draft analysis outputs (tables, listings, and graphs) to be incorporated into CSRs, integrated summaries and New Drug Applications (NDAs)

  • Write drafts and/or review appropriate sections of the CSR

  • Work with Data Management staff to review CRF data, and interface with study personnel to resolve data queries

  • Conduct site visits for co-monitoring and auditing, as needed

  • Assume certain duties of other team members in order to meet project goals

  • Participate in interactions/meetings with regulatory authorities, as needed

  • Assist with IND and NDA coordination and preparation

  • Participate in bid defense presentations and meetings

  • Collaborate interdepartmentally on the proposal development process

  • Participate in the periodic review and revision of departmental policies and SOPs

  • Other duties as assigned

Required Education and Experience:

  • Bachelor’s degree (or equivalent) in life science, biological science, clinical research or any other healthcare field and 5 years experience as a clinical research professional with a CRO, pharmaceutical or biotechnology firm;
    OR
    Master’s degree (or other advanced degrees, e.g. MD, PharmD, PhD, etc.) in life science, biological science, clinical research or any other healthcare field and 3 years of experience as a clinical research professional with a CRO, pharmaceutical or biotechnology firm

  • Certification as clinical research professional (ACRP or SOCRA) is preferred.

  • Working knowledge of ICH-GCP guidelines and FDA regulation

  • Extensive understanding of clinical research principles and processes

  • Ability to apply working knowledge of clinical trial operations to manage overall project scope, budget and timelines

  • Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners

  • Dynamic individual with ability to lead and motivate team members

  • Strong verbal and written communication skills

  • Ability to work effectively both independently and in a team environment

  • Strong organizational and planning skills

  • Excellent interpersonal and professional skills

  • Excellent time management skills with the ability to prioritize responsibilities and multitask

  • Self motivated and detail oriented

  • Ability and willingness to travel for work purposes (domestic and international)

  • Proficient in Microsoft Office and able to learn appropriate software

LEAD LOGISTICS ADMINISTRATOR

Position Summary:

The Lead Logistics Administrator in collaboration with Clinical team leaders is responsible for training, mentoring and supervising Logistics Administrators (LAs). The Lead LA serves as the primary point of contact for administrative support to the site and clinical trial team. The Lead LA is also responsible for coordinating the day to day clinical study activities and maintaining the logistical aspects of clinical trials in compliance with protocol, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), local regulations, applicable Standard Operating Procedures (SOPs) and project-specific requirements.

Responsibilities:

  • Interview, on board, and train new LAs and other clinical personnel, as necessary

  • Coordinate LA team meetings, workload, and assignments, as necessary

  • Identify any issues within the team and provide continuous support to all members according to standards

  • Provide training and mentoring for LAs with regard to processes for clinical trial management, SOPs, GCP guidelines, and daily activities

  • Ensure compliance to all SOPs to achieve overall quality and objectives and provide appropriate feedback to employees

  • Develop and maintain effective relationships with all company employees at various levels of the organization

  • Participate in the conduct of annual performance evaluation for LAs. Supervise, train and mentor clinical interns, as necessary

  • Oversee LA activities in preparation for setting up, conducting, and completing a Clinical Trial. This includes, but is not limited to:
    Primary Trial Master File Duties

  • Assume primary responsibility for the setup, development, maintenance, and correspondence of the Trial Master File (TMF) for studies assigned

  • Set up and maintenance of electronic filing systems/setup of the Investigator Site File (ISF)

  • Track Ethics/Regulatory submissions and approvals for studies

  • Prepare, distribute, track, and file essential clinical trial documentation

  • Coordinate archiving of study documentation

  • CRA and Study Team Support

  • Assist Clinical Team Leads and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timeline

  • Point of Contact for CRA assistance with TMF or study-related material support

  • Arrange and participate in the organization of Investigator Meetings and Study Team Meetings including taking and distributing minutes and tracking of the final document
    Study Management Support

  • Assist the Clinical Project Manager and Clinical Team Leads in site selection process

  • Assist in initial composition of Operations Manual, Pharmacy Binder, and Investigator Site File (ISF) Binder, etc.

  • Manage and maintain study documents and trial supplies, e.g. Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites

  • Ensure that any clinical trial databases/tracking tools are set up and maintained throughout the trial

  • Create and maintain study contact lists for team/sites/3rd parties

  • Review study mailbox and file emails in appropriate mailbox folders

  • Assist in preparation and distribution of Study Newsletters/Study Correspondence to all participating sites on an ongoing basis

  • Set up finance systems accurately, process invoices and track payments for the trial for investigator and vendor payments

  • Assist with collating, tracking and shipping Case report Forms (CRFs) and data queries to Data Management

  • General study filing
    Other possible tasks may include:

  • Assist with designing of study logs, source document template, etc.

  • Arrange translation of advertisement material and patient documents

  • Assist CRAs on monitoring visits

  • Reorder clinical drug supplies for sites

  • Other duties as assigned

Required Education and Experience:

  • Bachelor’s degree (or equivalent) in scientific discipline

  • 2 years of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience). Prior experience in clinical research is preferred.

  • Working knowledge of ICH-GCP guidelines and FDA regulations

  • Strong verbal and written communication skills

  • Ability to work effectively both independently and in a team environment

  • Strong organizational and planning skills

  • Excellent interpersonal, professional and leadership skills

  • Dynamic individual with ability to lead and motivate team members

  • Excellent time management skills with the ability to prioritize responsibilities and multitask

  • Strong administrative skills

  • Excellent documentation and file management skills

  • Self motivated and detail oriented

  • Proficient in Microsoft Office and able to learn appropriate software

CLINICAL TRIAL ASSOCIATE

Position Summary:

The Clinical Trial Associate provides administrative and management support to the Clinical Department.

Responsibilities:

  • Spreadsheet and database creation and maintenance (e.g., study trackers, study contacts, site-specific regulatory documents, metrics, etc).

  • Maintain thorough knowledge of applicable Amarex Standard Operating Procedures (SOPs), guidelines and written study procedures for the project

  • Manage site start-up procedures, including site identification, feasibility questionnaire assessment, Institutional Review Board (IRB) submissions, contract/budget negotiations, direct monitoring activities and assist with site start-up questions

  • Assist with Case Report Form (CRF) review/writing, as required by the project team

  • Develop and/or review informed consent form templates

  • Establish and maintain clinical monitoring tracking tools, study tools and study templates for site personnel, with appropriate guidance and instructions, as needed

  • Participate in project team meetings and communicate in a timely and effective manner, with the appropriate internal or external individuals involved in the project. Prepare and distribute meeting agendas and meeting minutes, as required

  • Ensure weekly updates are obtained from project team members and provided to the Project Manager (PM) and/or Sponsor, as required

  • Coordinate timely shipment of clinical supplies and Investigational Product to sites according to the study-specific procedures

  • Assist with the development of study manuals, binders, tracking forms, and other study materials

  • Recommend processes that lead to timely and successful placement, completion and/or resolution of project tasks

  • Format, proofread and conduct preliminary review of documents

  • Distribute internal policies, procedures, and training materials

  • Communicate with sites and provide other in-house support to Clinical Research Associates (CRAs), Clinical Lead or PM, as needed

  • Act as back-up contact (phone and email) for CRAs, Clinical Lead or PM, when they are traveling

  • Maintain Clinical Department files, vendor files, and clinical site databases

  • Other general administrative support duties as assigned

Required Education and Experience:

  • Minimum of Bachelor’s degree (or equivalent) in scientific discipline (degree in life science, biological science or any other healthcare field is preferred.)

  • 2 years of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience). Prior experience in clinical research is preferred.

  • Working knowledge of International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP) and FDA regulations

  • Strong verbal and written communication skills

  • Ability to work effectively both independently and in a team environment

  • Strong organizational and planning skills

  • Excellent interpersonal and professional skills

  • Excellent time management skills with the ability to prioritize responsibilities and multitask

  • Self motivated and detail oriented

  • Ability and willingness to travel < 20% of the time (domestic and international)

  • Proficient in Microsoft Office and able to learn appropriate software

REGULATORY AND SCIENTIFIC ANALYST

Position Summary:

The Regulatory and Scientific Analyst performs all activities related to development, preparation, writing, reviewing and editing of integrated reviews of literature and related materials that summarize data from published papers and clinical studies for submission to clients, the FDA and other regulatory agencies.

Responsibilities:

  • Write technical reports summarizing scientific papers and clinical/non-clinical study reports.

  • Coordinate document preparation for submission to regulatory agencies, including IND, NDA, IDE and PMA items.

  • Assist in reviewing, developing, writing, and/or editing Investigator Brochures, annual reports and clinical protocols.

  • Prepare and integrate tables, graphs, and graphics for all documents.

  • Responsible for creating and editing all sections of IND and NDA documents/submissions.

  • Prepare and submit regulatory filing (DMF, IND, BLA, PMA, 510k) and supports program for electronic formatting of regulatory submissions.

  • Review reports, tables and listings for completeness and accuracy.

  • Interact with various departments to collect information and synthesize it into documents.

  • Develop procedures for new projects and provide guidance to other personnel or consultants.

  • Keep updated guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents, including ICH Guidelines.

  • Act as a member of study teams, clinical project teams and interdepartmental project teams.

  • Work with outside and internal database managers and statisticians to obtain data listings and analyses needed to support the preparation of Clinical Study Report/ publications.

  • Other duties as assigned.

Required Education and Experience:

  • Minimum Master’s degree in biological science or related field; PhD preferred

  • Extensive writing experience. Publishing scientific papers in peer-reviewed journals is strongly preferred.

  • Ability to work effectively both independently and in a team environment, contributing to a collaborative work atmosphere.

  • Strong verbal and written communication skills.

  • Experience in writing, reviewing, and preparing clinical study reports and regulatory submissions is preferred.

  • Strong presentation skills.

  • Strong analytical skills.

  • Strong Microsoft Office skills particularly in MS Word and Excel.

LOGISTICS ADMINISTRATOR I

Position Summary:
The Logistics Administrator I serves as the primary point of contact for administrative support to the site and clinical trial team. The Logistics Administrator I is also responsible for coordinating the day to day clinical study activities and maintaining the logistical aspects of clinical trials in compliance with protocol, International Council for Harmonisation guideline for Good Clinical Practice (ICH-GCP), local regulations, applicable Standard Operating Procedures (SOPs) and project-specific requirements.
Key Duties and Responsibilities:

The Logistics Administrator I will be involved in most activities in preparation for study setup, conducting, and completing a Clinical Trial. This includes, but is not limited to:

Primary Trial Master File Duties

  • Assume primary responsibility for the setup, development, maintenance, and correspondence of the Trial Master File (TMF) for studies assigned

  • Setup and maintenance of electronic filing systems/setup of the Investigator Site File (ISF)

  • Track Ethics/Regulatory submissions and approvals for studies

  • Prepare, distribute, track, and file essential clinical trial documentation

  • Coordinate archiving of study documentation

CRA and Study Team Support

  • Assist Clinical Team Leads and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines

  • Point of Contact for CRA assistance with TMF or study-related material support

  • Arrange and participate in the organization of Investigator Meetings and Study Team Meetings including taking and distributing minutes and tracking of the final document

Study Management Support

  • Assist the Clinical Project Manager and Clinical Team Leads in site selection process

  • Assist in initial composition of Operations Manual, Pharmacy Binder, and Investigator Site File (ISF) Binder, etc.

  • Manage and maintain study documents and trial supplies, e.g. Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites

  • Ensure that any clinical trial databases/tracking tools are set up and maintained throughout the trial

  • Create and maintain study contact lists for team/sites/3rd parties

  • Review study mailbox and file emails in appropriate mailbox folders

  • Assist in preparation and distribution of Study Newsletters/Study Correspondence to all participating sites on an ongoing basis

  • Set up finance systems accurately, process invoices and track payments for the trial for investigator and vendor payments

  • Assist with collating, tracking and shipping Case Report Forms (CRFs) and data queries to Data Management

  • General study filing

Other possible tasks may include:

  • Assist with designing of study logs, source document template, etc.

  • Arrange translation of advertisement material and patient documents

  • Assist CRAs on monitoring visits

  • Reorder clinical drug supplies for sites

  • Other duties as assigned

Required Education and Experience:

  • Bachelor’s degree (or equivalent) in scientific discipline

  • 1 year of relevant experience in healthcare setting, preferably within the pharmaceutical/biotech industry (or alternatively, an equivalent combination of education, training and experience) is preferred.

  • Strong verbal and written communication skills

  • Ability to work effectively both independently and in a team environment

  • Strong organizational and planning skills

  • Excellent interpersonal and professional skills

  • Excellent time management skills with the ability to prioritize responsibilities and multitask

  • Strong administrative skills

  • Excellent documentation and file management skills

  • Self motivated and detail oriented

  • Proficient in Microsoft Office and able to learn appropriate software

IT HELP DESK TECHNICIAN LEVEL 1

Position Summary:
The IT Help Desk Technician Level 1 is responsible for end user support, upgrades, customization, and system integration.
Responsibilities:
• First point of contact for troubleshooting of IT problems; resolving the problem if possible, with an appropriate sense of urgency. Provide IT support to end users, both on- and off-site
• Provide IT systems orientation to new staff members
• Install, test and configure new workstations, peripheral equipment and software
• Provide mobile and IP telephony phone support
• Online services administration and support (electronic signatures, e-mail security, file sharing, mobile devices, online meeting, etc.)
• Develop instructional documents
• Perform timely workstation relocation as required
• Keep abreast of IT technology
• Other duties as assigned
Required Education and Experience:

• Bachelors degree and one (1) year of related experience or equivalent education and experience
• Understanding of IT systems best practices, including the documentation and testing of systems
• Expertise in maintaining MS Windows desktop  installations
• Experience in Active Directory, Microsoft Exchange, Microsoft Office, mobile OS (iOS & Android), and PDQ Deploy
• Ability to work overtime when necessary
• Ability to work independently with minimal supervision
• Strong problem-solving skills and the ability to develop alternative solutions
• Strong customer-service orientation which includes effective interpersonal skills and the ability to work in a team environment

PROGRAMMER ANALYST I

Position Summary:

The Programmer Analyst I is a computer programming position responsible for delivering technical services relating to clinical trials data. This includes working with Electronic Data Capture (EDC) and other data management applications to achieve project integrity and the delivery of on-time, quality data. The Programmer Analyst I analyzes the feasibility of program requirements to develop applications that meet FDA guidelines.

Responsibilities:

  • Identify, evaluate and solve clinical data collection problems

  • Develop and implement clinical data collection methods that meet FDA guidelines

  • Test, document, and validate clinical data collection computer systems

  • Develop user manuals

  • Demonstrate and train users on the application

  • Support user acceptance testing

  • Provide maintenance for user requested changes to the application/database

  • Provide support for proprietary data management computer applications

  • Other duties as assigned

Required Education and Experience:

  • Bachelor's degree in computer science or related field of study and 1 year of related experience OR equivalent education and relevant experience

  • Working knowledge of relational databases (Postgres, SQL Server)

  • Working knowledge of ASP .NET, C#, IIS, Java, J2EE, JavaScript/JScript, and Visual Basic .NET

  • Strong verbal and written communication skills

  • Extremely detail-oriented with excellent follow-up skills

  • Ability to work independently with minimal supervision

  • Effective interpersonal skills, including the ability to work in a team environment, contributing to a collaborative work atmosphere

To submit your CV for our consideration, please email us at jobs@amarexcro.com.

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