Clinical Research Associate

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