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: 

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.

QUALITY ASSURANCE AND CLINICAL SPECIALIST

Position Summary:

The Quality Assurance and Clinical Specialist (QACS) participates in company-wide compliance activities both internally at the Amarex office and externally at clinical sites managed by Amarex employees. He/She performs monitoring/auditing visits to ensure compliance with ICH-GCP guidelines, local regulations, corporate SOPs and project-specific requirements.

Responsibilities:

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

  • Ensure compliance with FDA regulations, ICH/GCP, and SOPs for projects filed under a U.S. IND, IDE or other FDA requirements

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

  • Assist in design, writing, and review of draft SOPs

  • Review reports to applicable SOPs and FDA regulations and guidelines

  • Co-monitoring and auditing, as needed

Required Education and Experience:

  • Minimum BS in related field 

  • Two years of clinical trial experience with a CRO, pharmaceutical or biotech firm

  • Two years of experience in quality operations such a quality control, quality assurance, auditing, training, and documentation management

  • Working knowledge of Good Clinical Practices (GCPs) and project management

  • Proficient in Microsoft Office software, Adobe Acrobat, related software

  • Ability to organize and prioritize work in order to meet demanding timelines

  • Strong problem solving, interpersonal and communication skills

  • Willing to travel to meet corporate and project goals

  • Other duties as assigned

PROJECT ACCOUNTS PAYABLE ASSISTANT

Position Summary:

The Project AP Assistant supports the clinical team and the accounting team by processing project-related expenses.  

Responsibilities:

  • Assist in tracking and processing pass-through expenses for all projects

  • Coordinate with clinical team regarding project status to determine validity of third party invoices

  • Prepare payment request forms and submit to accounting for billing to clients

  • Respond to client inquires regarding pass-through expenses

  • Other duties as assigned

Required Education and Experience:

  • Bachelor’s degree (or equivalent) in scientific or business 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) or in accounts payable is preferred.

  • Strong verbal and written communication skills

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

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

  • Strong administrative and follow-up skills

  • Excellent documentation and file management skills

  • Self motivated and detail oriented

  • Proficient in Microsoft Office and able to learn appropriate software

  • Good interpersonal skills and ability to work in a team environment contributing to a collaborative work atmosphere

ASSISTANT MEDICAL WRITER

Position Summary:

The Assistant Medical Writer assists in preparation, development, Quality Control (QC), and review for accuracy of Clinical Study Reports and related materials for submission to clients, the FDA and other regulatory agencies.

Responsibilities:

  • Assist in reviewing/QC tables and listings for completeness and accuracy as document preparation for Clinical Study Reports.

  • Assist in QC for accuracy of Clinical Study Reports sections and publications.

  • Assist in reviewing/QC for accuracy of various documents (including clinical protocols) to support all phases of clinical product development.

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

  • 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.

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

  • Assist as a member of the study teams and clinical project teams.

  • Assist in the interaction with various departments to collect study information.

  • Other duties as assigned.

Required Education and Experience:

  • Bachelor’s degree (biology. chemistry, or mathematics disciplines preferred)

  • Extremely detail-oriented with excellent follow-up skills.

  • Strong verbal and written communication skills.

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

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

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

SAFETY COORDINATOR

Position Summary:
The Safety Coordinator will assist in data entry of adverse events, reviewing the data and communications such as query generations in Clinical Trials.
Responsibilities:

• Enter incoming data into related tracking systems and databases
• Handle incoming data from clinical trial sites
• Follow the company and department SOPs and other regulatory guidelines, if required
• Write data summary narratives and reports, as needed
• Perform data reconciliation for ad hoc and annual reports
• Organize, attend and take minutes of meetings
• Provide administrative/logistical support
• Other duties, as assigned e.g. assist with coding activities

Required Education and Experience:

• Associate or bachelor’s degree in scientific or health-related curriculum, or equivalent professional experience
• Competent in the use of Microsoft Office software
• Ability to work effectively both independently and in a team environment
• Strong problem solving, decision making, and follow-up skills
• Strong verbal and written communication skills
• Written communication abilities to include drafting of memos, formatting, and taking minutes
• Good interpersonal skills and ability to work in a team environment contributing to a collaborative work atmosphere

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.

AMAREX_NSF_1C.png
  • Facebook Social Icon
  • Twitter Social Icon
  • LinkedIn Social Icon
  • YouTube Social  Icon

           

           © 2020 Amarex Clinical Research, LLC, an NSF International company. All rights reserved.                                                                                                                                                                                                  Top of Page 

Contact     Privacy Policy     Clinical Site Registration     WebView

NSF Mark_100x100.jpg