About the Opportunity
We are partnered with a clinical-stage biopharmaceutical company located on the East Coast that’s currently in need of a Senior Clinical Research Associate that specializes in Phase 1 Oncology. This role is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOP. This is a fantastic opportunity to join a company that has several assets in various stages of clinical trials for solid tumor and hematologic indications. This is a remote position, but the right fit will ideally live near an airport hub and be flexible to travel.
The annual base salary range is $100,000 to $140,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits
- Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites
- Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
- Assist in the development of study/program plans (i.e.., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.).
- Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters, or other potential creative solutions)
- Monitor recruitment, data quality and patient safety while on site and remotelyt hrough EDC systems and direct site communication
- Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
- Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondence
Job Requirements
- BA/BS in health science or related field
- 5+ years of monitoring experience
- Experienced in Phase 1 Oncology
- Remote, but ideally near a major hub airport and flexible to travel
