Clinical Trial Associate/Coordinator

Clinical Trial Coordinator/Associate,

Infectious Disease, Vaccines, CRO Management, Unblinded

Home Based Position

CONTEXT (client background / the program)

Our innovative healthcare client is seeking a strong Clinical Trial Coordinator to support a large clinical program team with clinical coordination and with study administrative support. This team is working on a high visibility & fast paced Vaccine study. This study is outsourced and then has an internal core team comprised of internal employees. This Clinical Trial Coordinator/Associate will help with tracking, meeting minutes, clinical data listing reviews, administrative tasks, coordination, etc. This CTA will be unblinded while many of the other team members will be blinded. It is important that this individual is flexible and adaptable and willing to help wherever the team needs. This is a very faced paced work environment.

QUALIFICATIONS

1) Clinical Trial Coordination/Associate experience: The ideal candidate will have experience support a Sr Clinical Study Manager or Portfolio Manager will Clinical Trial Coordination activities (ideally working for a Sponsor or CRO organization)

2) 3+ years of Clinical Research Experience: The ideal candidate will have at least 5 years within a pharmaceutical company or CRO.

3) Vendor & CRO Management/Collaboration: This role will work closely with CRO’s and will need to collaborate closely with vendors.

4) Technology Savvy: This role will be benefitted by an individual who is a quick learner and able to utilize different software technologies.

5) Bachelor’s Degree (Scientific Field Preferred)

ADDITIONAL QUALIFICATIONS / NICE TO HAVES

1) PMP Certification

2) Previous CRA Experience

3) Infectious Disease

4) Vaccines experience

5) Unblinded Study experience

6) Eastern or Central Time Zone (or ability to work within EST Core Biz Hours)

RESPONSIBILITES

• Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to client systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff)
• Coordinate Project Team and departmental meetings, including associated documentation
• Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines
• Develop and maintain strong, collaborative relationships with key stakeholders within client, its CROs, and clinical sites
• Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs
• Assist with vendor / clinical site agreements, budgets and reconciliation / tracking of purchase orders and invoices for assigned trials
• Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems

LOCATION & TRAVEL

Client and Team are located in Boston Area. This is a remote position with minimal travel as needed

START & TERM

ASAP, 6-month initial contract with long term duration (strong likelihood for extension or conversion to fte)