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Senior Clinical Research Associate
2 months ago
We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at GenesisCare. As a Senior CRA, you will play a critical role in the management of clinical trials, ensuring that projects are conducted in accordance with applicable SOPs, regulations, and ICH guidelines.
Key Responsibilities- Act as a member of the project team to contribute towards efficient management of trials.
- Perform Site Qualification Visits to ensure that trial staff and site facilities are in accordance with protocol requirements, local regulations, ICH-GCP, and GC CRO's SOPs.
- Support feasibility, site selection, and start-up activities, including leading the preparation of Human Research Ethics Committee (HREC) submissions with sites.
- Negotiate site budgets and assist with the execution of site contracts with support from the Project Manager.
- Perform Site Initiation Visits to train Investigators and other trial staff in the protocol and data collection methods.
- Perform Interim Monitoring Visits to ensure adherence to protocol, monitor participant source data, and perform Investigational Product accountability.
- Perform Site Close Out Visits.
- Oversee all aspects of study site management to ensure high-quality data.
- Maintain eTMF filing and study tracking in Clinical Trial Management System (CTMS) in a timely manner.
- Manage timely site payments.
- An Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
- At least 3-4 years' experience in monitoring clinical trials in CRO, Pharmaceutical, and/or Biotechnology industry as a SCRA/CRA.
- Experience in managing early phase oncology trials is highly preferred.
- Experience in EDC & CTMS.
- Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
- Experience in contracts negotiation desirable.
- Experience in HREC submission preparation.
- Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management.
- Willingness to travel to fulfill the requirements of the role.
By joining GenesisCare, you will be part of a highly progressive and passionate team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes. We are a leading provider of cancer care services, with a team of over 2,000 employees across 50 locations nationally.
We are committed to providing a supportive and inclusive work environment that allows our employees to grow and develop their careers. We offer a range of benefits, including professional development opportunities, flexible working arrangements, and a comprehensive employee assistance program.
We are an Equal Opportunity Employer and welcome applications from diverse candidates. If you are passionate about delivering high-quality care and making a difference in the lives of our patients, we encourage you to apply for this exciting opportunity.
