Clinical Research 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 a Senior Clinical Trial Manager 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.
- 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
- 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 guidelines, Code of Federal Regulations and study-specific plans 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, within the biotech/pharmaceutical industry
- 1+ 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 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
- Experience working with Electronic Data Capture systems as well as Microsoft Office applications including MS Word, Excel, PowerPoint and Outlook, Cloud based storage platforms as well as calendaring programs and database applications required.
- 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 20%.
How to Apply
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 email@example.com.
Thank you for your interest in Pionyr Immunotherapeutics. We are an equal opportunity employer.