Clinical Research Associate
4000 Shoreline Court, Suite 250 South San Francisco, CA 94080
Clinical Research Associate
South San Francisco, CA
The Clinical Research Associate is a key member of the team responsible for planning, successful implementation and management of one or multiple clinical trial(s). Responsibilities include assisting in the development of study protocols, case report forms, clinical reports, performing site monitoring visits, and interfacing with site coordinators, field clinical staff, CROs and other company representatives. High level relationships across all functional areas that interact with Clinical Operations (including Product Development, Research, Translational Medicine, etc.) will also be required.
- Maintain and/or accelerate timelines for achieving clinical operational milestones
- Serve as the primary liaison with research sites; monitor the day-to-day conduct of the study, and resolve problems associated with the study; provide administrative and logistical support as needed
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
- Participate in the design of study manuals, etc.
- Participate in site start-up, interim and close-out activities, etc.
- Interact with the clinical study sites to resolve data queries and/or data entry errors, and obtain additional information on potential serious adverse events
- Monitor clinical studies to ensure the quality, integrity and completeness of data verified against source documentation both on site and remotely
- Review study records including case report forms, consent forms and other materials; may perform site visits to ensure regulatory and study requirements are being fulfilled
- Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones; serve as a resource to site coordinators, investigators and other staff members regarding investigational products and protocols; monitor and track progress and obstacles
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
- Assist in identification and hiring of appropriate CROs and third party study vendors. Assist in evaluation of the performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identifying areas of concern and escalating to the Sr. Director, Clinical Operations.
- Assist in preparation, negotiation and management of and adherence to study budgets; perform initial review of CRO and vendor invoices
- Assist in the development and implementation of enrollment strategies
- Bachelor’ s degree in a scientific or health care discipline preferred and/or training or equivalent combination of education and experience. Advanced degree(s) in scientific research, medicine, nursing, law, or business is a plus
- 1-2 years experience in oncology and/or orphan drug development strongly preferred
- 3+ years experience in the role of Clinical Research Associate preferred
- Experience in the preparation, monitoring, and execution of clinical studies is a plus
- Ability to motivate clinical site personnel to maintain/accelerate timelines in order to achieve clinical operational milestones
- Some understanding of medical/therapeutic area knowledge and medical terminology is a plus
- An understanding and demonstrated application of Good Clinical Practices and ICH Guidelines is a plus. Able to comply with safety standards and respect privacy and confidentiality
- Superb verbal and written communication skills
- Excellent organizational skills along with strong attention to detail
- Ability to work collaboratively with cross-functional teams
- Some domestic and international travel would be required for site training, monitoring responsibilities, etc. Ability to travel approximately 20%.