Clinical Research Associate
Clinical Resource Associate
Pionyr Immunotherapeutics Inc., a growing South San Francisco-based immuno-oncology company focused on novel approaches to cancer immunotherapy, is seeking a Clinical Research Associate (CRA). The Clinical Research Associate will be a key member of the clinical team responsible for supporting the planning, successful implementation, and management of one or more clinical trial(s). This is an in-house position and we are looking to hire a local candidate. The CRA will report to Pionyr’s Sr. Director, Clinical Operations and will work closely with our clinical operations and regulatory staff.
Specific Responsibilities include (but not limited to):
- Assisting in the development of study protocols, case report forms, clinical reports, site monitoring visits, and interfacing with site coordinators, field clinical staff, CROs and other company representatives.
- Build effective relationships across all company functional areas that interact with Clinical Operations as well as with personnel at assigned clinical sites.
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements. Responsible for clinical study document archiving according to regulatory and industry standards.
- Participate in the design of study manuals, document archiving structure, etc.
- Participate in site start-up, interim and close-out activities, etc.
- 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.
- Assist in tracking and managing shipments of biological specimens and study-related supplies.
- 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 and responding to day-to-day problems.
- 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
- Maintain all trial files and other related documents, including trial master file and oversight of site files
- Perform other duties as requested
- 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, nursing, or business is a plus
- 2-3 years’ experience in supporting clinical studies and drug development strongly preferred
- 1+ years’ experience in the role of Clinical Research Associate required; industry oncology experience strongly preferred
- Experience in the preparation, monitoring, and execution of clinical studies is a plus
- Ability to motivate clinical site personnel to maintain/accelerate to achieve clinical operational milestones
- 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. Agree to adhere to regulatory and industry standards on document archiving.
- Superb verbal and written communication skills. Excellent organizational skills along with strong attention to detail. Ability to work collaboratively with cross-functional teams, external vendors and clinical site staff
- Ability to effectively work in a fast-paced environment supporting multiple priorities
- Some domestic and international travel may be required for site training, monitoring responsibilities, etc. Ability to travel up to 25%.
Pionyr Immunotherapeutics Inc. offers competitive salaries, participation in company stock-incentive plans and benefits packages, in addition to a dynamic academic-driven science environment.If you would like to be part of a team-based and collaborative company developing innovative immuno-oncology therapeutics, please send your resume to firstname.lastname@example.org.