Clinical Research Associate / Sr. Clinical Research Associate
Antiva Biosciences a growing first-in-class women’s health and virology company based in the San Francisco Bay area and focused on empowering patients globally with the first ever at-home treatment for HPV related diseases to prevent cancer, is seeking a Clinical Research Associate / Sr. Clinical Research Associate (title commensurate with experience). This role 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/Sr. CRA will report to an Associate Director, Clinical Operations and will work closely with our clinical operations team.
Specific Responsibilities Include (but not limited to):
- Assist in the development of study protocols, informed consent forms, case report forms, clinical reports, and site monitoring visit report templates.
- Build effective relationships across all company functional areas that interact with Clinical Operations as well as with site and CRO personnel.
- Assist in evaluation of the performance of CROs, third party vendors, and including quality oversight co-monitoring visits with CRO field CRAs, to ensure compliance with study protocol and in accordance with scope of work.
- May assist with vendor management and oversight including CROs.
- Participate in site ID and feasibility activities in collaboration with study lead and CRO counterparts.
- Participate in the development of project plans such as monitoring plan, data review plan, vendor plans, and study manuals such as study operations binder and pharmacy manuals as well as other project related materials.
- Participate in CRO oversight of site start-up, interim and close-out activities, including review of monitoring visit reports.
- Assist in tracking and managing shipments of biological specimens and study-related supplies.
- May attend and participate in investigator/study coordinator meetings and assist in training site coordinators, investigators, field clinical staff, CRO (as applicable).
- 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.
- May assist in preparation, negotiation and management of and adherence to study budgets.
- Perform initial review and processing of CRO and vendor invoices.
- Ensure assigned project(s) are inspection ready by participating in maintenance of all trial files and other related documents, including trial master file oversight.
- 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 a Clinical Research Associate role with field monitoring experience.
- Experience working with Electronic Data Capture systems as well as Microsoft Office applications, Coud based storage platforms, and clinical database applications required.
- Superb interpersonal, verbal and written communication skills.
- Able to work collaboratively with cross-functional teams, external vendors and clinical site staff as well as independently.
- Able to motivate clinical site personnel and CRO counterparts to achieve operational milestones.
- Able to effectively work in a fast-paced environment supporting multiple priorities.
- Able to deliver and receive constructive feedback.
- Demonstrate excellent understanding of and application of Good Clinical Practices and ICH Guidelines.
- Able to identify and comply with safety standards and appropriately handle and maintain confidentiality.
- Outstanding attention to detail and strong organizational skills.
- Solutions oriented problem-solving skills a plus.
- Some domestic and international travel may be required for site training, study monitoring and oversight responsibilities. Ability to travel up to 20-25%.
How to Apply
To apply, please mail or email your CV and cover letter to:
Antiva BioSciences, Inc.
Attn: Human Resources
280 Old County Road #257
Brisbane, CA 94005
Antiva is an equal opportunity employer.