Clinical Research Associates needed for a full time, temp to perm job in Boston, Ma.
The in-house CRA is responsible for managing various aspects of the site management strategy, including but not limited to administration of the CTMS system, Study trial master file set up and maintenance, CRO vendor oversight, and site feasibility and start up activities.
ROLES AND RESPONSIBILITIES:
- Assist the Site Manager in supporting the member sites and act as the back up to the Site Manager when dealing with site related issues
- Send, track and review feasibility questionnaires (study specific and global)
- Assist with collection of essential documents related to study start-up (if no CRO performing task) and will review IP release
- Filing of study documentation in electronic Trial Master File (eTMF)
- Act as document manager within eTMF
- Assist in monitoring email accounts related to studies
- Assist with creation of start-up plans and templates
- Quality Review of eTMF: Ensures proper and timely filing of all relevant study documents on an ongoing basis; to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and AFT expectations. Performs routine review of filing procedures to ensure adherence to current guidelines at all
- Assist with tracking, training information and issuing training for sites and
- Enter training information under contacts within CTMS to track training completed that could carry over to other
- Assist with site follow-up on accrual
- Review of monitoring reports in CTMS to identify deficiencies, adequacy of issue escalation and issue resolution and provide feedback on review to appropriate CRO
- Participate in co-monitoring
- Communicates with CROs, Vendors, and/or study sites as necessary to support the study
- Maintain site information and roster in the AFT Clinical Trial Management System (CTMS).
- Conduct regulatory review of ICF changes and coordinate review by executive officer and senior contracts manager (legal purposes).
- Assist with site selection and recruitment by generating site identification reports (e.g., site accrual), collecting, reviewing and tracking site feasibility/credentialing
- Assist with preparation and execution of Investigator meetings and other site training programs.
- Organize study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as
- Other related duties as assigned by clinical/OD or site management to meet departmental and company objectives
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- A minimum of a BA/BS degree is
- Degree in a health or science major
- 2 – 4 years relevant biotech/pharma, and/or CRO, with 1-year industry experience
- Working knowledge of clinical monitoring responsibilities and
- Working knowledge of Clinical Trial Master File
- Software skills should include MS Office (Excel and Word)