Title: Clinical Research Associate
Salary: $120,000-$150,000
Company Summary: We're partnered with an ADC focused Biotech company that is currently building out their Clinical Operations team to support their innovative pipeline with therapies ranging from Phase 1-3. As I'm sure you are well aware, ADC's are seen as the future of how we will tackle Cancer in an innovative yet more plausible way compared to other less scalable treatments like Cell Therapy that is still decades away of being accessible to the average cancer patient.
The Clinical Research Associate will be responsible for:
- Conduct Site Evaluation, Site Initiation, Interim Monitoring, and Close-Out Visits.
- Prepare the study reference manual, coordinating with the CRO team to ensure efficient delivery of materials to investigator sites.
- Ensure investigator sites meet all contractual and regulatory requirements for initiation and the first release of study drugs.
- Assist in developing study/program plans, including the Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, and Safety Management Plan.
- Manage patient recruitment strategies, identify barriers, and propose solutions such as webinars and newsletters.
- Liaise with site personnel to ensure accurate and timely data entry into the eCRF and resolve data queries promptly.
- Maintain project files, including ethics approvals, investigator CVs, study materials, and site correspondence.
- Assist with data listing, coding, patient profile reviews, database lock, and site close-out activities.
- Ensure timely submission of documents to the Trial Master File.
- Conduct investigational product inventory and reconciliation, ensuring compliance with protocol for dispensing and administration. Verify any issues related to blinded or randomized information.
The Clinical Research Associate should have the following qualifications:
- 5 years monitoring oncology trials independently conducting on-site and remote monitoring visits
- 5-7 years of experience in oncology trials
- Ability to travel as required (50-75%)
Benefits
- 401k with company matching.
- Health insurance with excellent family plan.
- Pre-IPO with equity offerings.
