Job Description Responsibilities:

• Identify and assess sites and investigators through feasibility questionnaires and pre-study visits.
• Support PM to prepare the IRB submission documents, TMF filing and tracking study documents and versions particularly those required for IRB submission, site activation, and study start-up
• Provide study training and maintain good work relationships with site staff, motivate site staff to deliver high quality work within study timelines
• Manage study sites by monitoring activities for site initiation visits, interim monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
• Prepare monitoring visit agenda, confirmation letter, visit report and follow up letter to accurately document site status and activities
• Verify study records (e.g., source documents, CRFs, AEs/SAEs and PDs) are tracked and reviewed for completeness and accuracy to ensure data integrity and study subject safety.
• Reconcile clinical supplies and drug accountability records at study sites.
• Review, clarify and obtain data changes via query resolutions with site personnel and data management.
• Identify and document site findings, re-train, put corrective action in place and follow up with compliance as required.
• Assist in the coordination and planning of study meetings (e.g. Site calls, Investigator Meetings, Kick-off meetings).
• Review, track and reconcile study files in-house and on-site, collect or distribute outstanding documents as needed, maintain site in audit/inspection readiness.
• Assist with effective and timely audit and inspection responses
• Acquire a basic knowledge of the therapeutic area and product, participate in study documents draft and review.

Perform regulatory document review and approval for IP release.

Requirements:

• Bachelor's degree in the life science field is required.
• Requires 2-3 years of experience in clinical research, including a minimum of 1-2 years of field monitoring experience with site management, and oncology experience preferred. Good knowledge of medical terminology, clinical trial process, regulatory requirements, ICH/GCP guidelines, and SOPs.
• Ability to learn and adapt quickly to new systems and challenges.
• Good knowledge of CTMS, eTMF, EDC and IRT
• Strong verbal and written communication skills.
• Ability to meet deadlines, multitask, and prioritize based on study needs.
• Ability to establish rapport with site personnel/ colleagues.
• High work ethics that require minimum supervision.
• Ability and willingness to travel at 40%.
• Work on site in Burlington MA.

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Vision insurance Application Question(s): Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)? Are you willing to undergo a background check, in accordance with local law/regulations? Are you comfortable working in an onsite setting?

Education:

Bachelor's (Preferred)

Experience:

CRA:

2 years (Preferred)

Work Location:

In person