Clinical Trial Associate/TMF Archivist
Premier Research - Quincy, MA

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POSITION SUMMARY:
Supports the Project Team by assisting in the administrative organisation and management of projects ensuring compliance with Premier Research drug and/or device SOPs, Sponsor and ICH-GCP/ISO14155 requirements. This position may also involve general office administration tasks. The role involves high utilisation of PC-based software packages for word processing, spreadsheets, and graphics. Position will be office based.

PRIMARY JOB FUNCTIONS:
Manages administrative support and tasks for the Clinical Project Team, including but not limited to filing, faxing, memos, letters and photocopying support for designated project team(s), as required; prepares study documents at the direction and oversight of the Project Manager

Attends project team meetings, prepares meeting agendas and minutes, and maintains action item lists from meetings

Creates and maintains active study files, including Trial Master File according to Premier-Research Group or client SOPs

Collects and tracks regulatory and other relevant documents for submission to Central/Local IRB, Ethics Committees, Competent Authorities and others, as appropriate

Verifies IRB/EC approvals and collects and tracks other required regulatory documents

Maintains study enrollment tracking and study status spreadsheets, as appropriate

Distributes study materials to investigator sites, Sponsors and team members, as needed

Prepares documents for and distributes various investigator, regulatory, operations, guidelines and training manuals

Assists in preparation for investigator and project launch meetings

Assists in preparation for and attends client meetings

Supports clinical monitoring staff for visit preparation regarding regulatory document tracking and other study file correspondence

Performs additional duties and assignments as requested

May assist with protocol deviation tracking and adverse event reporting, if required

May accompany CRAs on occasional site visits, if required

May assist CRAs in in-house monitoring activates such as CRF page separation, tracking and onward distribution

May support the Start-Up Manager in the feasibility process and in the submissions to Ethics Committees and Competent Authorities

OTHER RESPONSIBILITIES:
To update CV and Training records as necessary and make available for client review where appropriate

Remains alert for new business opportunities, network, and provides information to business development staff or manager

Communicates via electronic mail acknowledging and sending correspondence in a professional, timely manner

Performs other project related duties as assigned by the Project Manager

Performs other work-related duties, as assigned

Responsible for the liaison with the Premier Research Archive, including management of the dispatch and retrieval of all documents to be archived

May be involved in general office logistical activities

Required Skills

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment is essential

Requires strong planning and organisational skills, verbal, written

Well developed communication skills, good at listening and sharing information with others

Ability to act on own initiative within inter-related team communication

Collaborative approach to create an effective team and meet deadlines

Quality and detail oriented with high standards

Must be dependable and meet commitments

Applies clear and consistent performance standards and handles problems decisively and objectively

Strong computer skills in Word, Excel, and email are necessary

Fluent verbal and written English language is essential

School certificate or equivalent required. Bachelors’ degree (BS, BA, or RN equivalent) in a biological or science-related field preferred

Prior experience as a CTA preferable

Location: Quincy, MA office

Required Experience

Premier Research - 16 months ago - save job - block
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