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: 

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

REGULATORY ASSISTANT

Position Summary:

The Regulatory Assistant works with the regulatory team coordinating activities regarding submission of documents to FDA and other governing bodies. Other responsibilities may include team progress tracking and project management. This position is entry-level.

Responsibilities:

  • Compile and review regulatory submissions in paper and eCTD formats

  • Format and proofread of documents

  • Coordinate internal and client meetings

  • Assist in preparation of meeting minutes

  • Track ongoing projects in the department for completion and pending tasks

  • Monitor time-line adherence of ongoing projects

  • Participate in quality assurance processes

  • Assist in preparation of numerous communications including memos, correspondence, SOPs, guidelines and presentations

  • Distribute internal policies, procedures, and training materials

  • Other duties as assigned

Required Education and Experience:

  • Bachelor’s degree and up to 1 year of related experience or a combination of equivalent education and relevant experience

  • Strong verbal and written communication skills

  • Proficient in MS Office software

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

ACCOUNTING ASSISTANT

Position Summary:

The Accounting Assistant is responsible for supporting the Accounting Department staff to fulfill administrative and accounting responsibilities.

Responsibilities:

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

  • Track and report all internal copy expenses, web ex calls, material reimbursements, etc. and prepare for invoicing to sponsor.

  • Maintain spreadsheets and files and produce final PDF for invoicing.

  • Assist with tracking of Independent Contractor invoices.

  • Review monthly invoices.

  • Record client payments.

  • Track, prepare, and submit commission reports.

  • Submit invoices.

  • General filing and scanning of documents as needed.

Required Education and Experience:

  • Bachelor’s degree in an accounting-related field.

  • Strong verbal and written communication skills.

  • Proficient in MS Office software.

  • Ability to work independently with minimal supervision.

  • Ability to work in a team environment, contributing to a collaborative work atmosphere.

INFORMATION TECHNOLOGY ADMINISTRATOR

Position Summary:
The IT Administrator is responsible for the support, performance, and functionality of the system environment, including end user support, upgrades, customization, and system integration.
Responsibilities:
• Ensure data is backed up on a regular basis
• Oversee general administration of Windows desktop applications. Carry out computer “housekeeping” tasks – including migrations, patches, and upgrades
• Deploy new workstations/laptops to users
• Provide IT support to end users, both on- and off-site. resolving the problem if possible, with an appropriate sense of urgency
• Troubleshoots and solves network connectivity problems, including monitoring the network and servers for problems, diagnosing problems, and taking the appropriate corrective measures to ensure 

   an expedient resolution
• Install, administer, support, and maintain server hardware, peripherals, software, and operating systems
• Provide input into IT strategy and acceptable use policy
• Keep abreast of IT technology
• Other duties as assigned

Required Education and Experience:

• Bachelor’s degree and two (2) years 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/server installations
• Strong technical knowledge of MS Exchange, SQL Server, VMWare and Office is required
• Experience in Acronis TrueImage, PDQ Deploy, Symantec EndPoint Protection, and Unitrends Recovery is desired
• 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

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

           

           © 2019 Amarex Clinical Research, LLC. All rights reserved.                                                                                                                                                                                                                                                   Top of Page 

Contact     Privacy Policy     Clinical Site Registration     WebView

NSF Mark_100x100.jpg