Lead CRA, Phase II (Infectious Disease/Immunology) – RTP, NC BioPharma – Local Candidates Only – Contract or Direct Hire
Our client, an RTP-area Biopharmaceutical company with products in the infectious disease space, is actively recruiting for a highly capable Lead CRA to join its R&D team.
This company is building. This Lead CRA will drive Study Site Feasibility and Start-Up for a national phase II trial, before becoming the Lead CRA on the trial. Duties will include involvement in vendor selection and oversight, as well as investigator selection, study start up, study conduct, site monitoring and data collection.
This role is based in the Raleigh, NC area, most work will be done remotely but we seek a candidate able to go onsite, to the RTP area office 2 days a week, for the first several weeks and travel as needed (when travel opens up).
We seek a versatile and “can do” Lead CRA whose clinical research knowledge is complemented by practiced and proven project management capabilities. A lot is happening and we seek a candidate who thrives in a “hub” role.
Specific duties will include:
Lead site identification and study set up
Lead CRA performing site qualification, site initiation, interim monitoring, site management activities and close-out visits for study sites (remotely for now, but may be performed on-site down the road)
Oversee and manage vendors, as well as review and approve invoices
Coordinate, review, track and manage production of key deliverables for clinical trials, including protocols, case report forms, statistical analysis plans, data management plans, clinical study reports and other essential trial documents
Ensure monitoring visits and reports are meeting clinical monitoring plan expectations
Ensure supplies are maintained at sites
Manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
Ideal candidate will offer a related degree (BS expected) and 5+ years of Lead CRA experience. Experience monitoring and managing Phase II clinical studies will be required. Experience with respiratory infectious disease or immunology trials is a strong plus. Pharma side and small company experience is strongly preferred.
In addition, we seek a very sharp, knowledgeable and organized professional who will work exceedingly well in a dynamic and collaborative setting; One who can gain the respect and cooperation of all stakeholders in order to achieve shared success.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.