Senior CRA (CRO Oversight/~30%Travel) – RTP Biotech/Immuno-Oncology
Our client, an RTP-area biopharmaceutical company that is developing immunotherapies to fight cancer and other diseases, is actively recruiting for a highly capable and knowledgeable Senior CRA to assume key role on its R&D team.
This company is building. It has multiple products in development and is aggressively pursuing targets for its proprietary technology. The future is very bright and this Senior CRA will be critically involved in ensuring clinical monitoring activities are running smoothly. Company will pay industry-leading wage to attract and retain the right candidate.
Key Things to Note:
- The company is developing immunotherapies to treat various cancers as well as infectious disease (including COVID) and other ailments.
- Phase I and II trials are underway and additional trials are planned. Familiarity with managing early trials is required.
- This Senior CRA will be responsible for performing, overseeing and coordinating all aspects of the clinical trials including study start up, study conduct, site monitoring, data and document collection, etc. Seek candidate from biotech or pharma who is accustomed to driving these functions.
- The company employs CROs for most monitoring. Experience coordinating and overseeing the work done by CROs will be important.
- This role is based in the RTP, NC area and will be split between home- and office-based. This Senior CRA will be responsible for Phase I site monitoring and co-monitoring with CRO partners for phases II and beyond. Travel is estimated at 30% (when travel opens). Seek RTP area candidates only.
- This company is still developing its operating policies and practices. Seek candidate who enjoys a building environment and will bring the resourcefulness, initiative and can-do work style needed to be successful.
The Senior CRA will be the point-person for all clinical monitoring activities. A lot is happening, and we seek a candidate who thrives in a “hub” role.
Specific duties will include:
- Perform and oversee 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
- Participate in training and mentoring CRAs
Targeted candidate will offer a scientific degree (advanced degrees welcome) and 4+ years of clinical research and site monitoring experience. Background working directly for the sponsor (Pharma / Biotech) is also important.
Other priorities include:
- Experience with study start-up, vendor management, managing deliverables and study close-out
- Experience overseeing vendors, including CROs
- Experience monitoring complex trials is a plus; Oncology, immuno-oncology experience is desired but not required
- Excellent verbal and written communication
- Keen attention to details
- Longevity and growth in previous roles
Finally, 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.