PURPOSE/SCOPE: The in-house CRA is responsible for managing various aspects of site management and project management strategies, including but not limited to administration of the CTMS system, study trial master file set up and maintenance, CRO vendor oversight, site feasibility, and start up activities.
ROLE AND RESPONSIBILITIES
Assist operations team in supporting the Alliance member sites and escalate site related issues when necessary.
Send, track, and review study-specific and global feasibility questionnaires.
Assist with site selection and recruitment by generating site identification reports (e.g., site accrual); collecting, reviewing and tracking site feasibility/credentialing documentation and follow-up on site accruals accordingly.
Track training information and issue trainings for sites and contacts.
Collection of essential documents related to study start-up and review IP release packages.
Prepare for and execute Investigator meetings and other site training programs.
Assist with creation of start-up plans and templates.
Ensure proper and timely filing of all relevant study documents into the eTMF on an ongoing basis to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines and company expectations.
Perform routine review of filing procedures to ensure adherence to current quality guidelines at all times.
Accurately enter and manage data within the Clinical Trial Management System (CTMS) by: tracking completed training information that could carry over to other studies; maintaining site information and rosters; reviewing monitoring reports to identify deficiencies, reviewing adequacy of issue escalation and issue resolution; and provide feedback to appropriate CRO contacts.
Participate in co-monitoring activities.
Communicate with CROs, vendors, and/or study sites as necessary to support the study, which includes monitoring email accounts related to studies.
Conduct regulatory review of ICF changes and coordinate review by Executive Officer and contracts team
Coordinate study related meetings; take detailed minutes at meetings on decisions and action items and distribute to the team, as assigned.
Other related duties as assigned to meet departmental and company objectives.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
A minimum of a BA/BS degree is required.
Degree in a health or science major preferred.
2 – 4 years relevant experience in biotech, pharma, and/or CRO, including 1 year of clinical research industry experience.
Working knowledge of clinical monitoring responsibilities and procedures.
Previous experience with eTMF, CTMS, and IRT clinical trial systems is strongly preferred.
Proficient in Microsoft Office Suite, especially Word and Excel.
Strong organizational skills and ability to prioritize workload to meet tight deadlines in a fast-paced and dynamic work environment.
Strong interpersonal, written, and verbal communication skills.
Flexible and adaptable to a small business workplace environment
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