Clinical Research Associate; CRA/Sr. CRA
Position: Clinical Research Associate (CRA)/ Sr. CRA
Clinical Research Associate (CRA)/ Sr. CRA
Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody‑drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next‑generation biologics from concept to clinic.
This role is based in a remote work setting.
Summary
Fortvita is seeking a dynamic and experienced Clinical Research Associate I or II (CRA) to manage and monitor clinical trial sites to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practices (GCP). This role will play a critical role in driving the success of our clinical trials by supporting site selection, initiation, monitoring, and close‑out activities. The ideal candidate will demonstrate strong attention to detail, effective communication skills, and the ability to work both independently and collaboratively in a fast‑paced environment.
This role is based in a remote work setting.
Responsibilities
• Serve as Study Site Start‑Up activities coordinator in assigned studies for investigative sites, Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
• Perform site selection, start‑up, and activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Oversee the progress of clinical studies at assigned sites, ensuring accurate documentation, data integrity, patient safety, and protocol adherence. Review case report forms (CRFs) and source documents.
• Proactively encourage and facilitate site enrollment, helping implement tailored recruitment action plans, and providing motivational feedback and resources to site staff to maintain engagement and momentum in reaching enrollment targets.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Inform team members of the completion of regulatory and contractual documents for individual sites.
• Work with the Project Manager responsible closely for the budget and contract negotiation and sign‑off in a timely manner.
• Provide local expertise to the project team during initial and ongoing project timeline planning.
• Perform quality control of documents provided by sites.
• Maintenance of the eTMF until handed over to the site management team.
• Other duties as assigned.
Qualifications
Required
• Bachelor’s Degree in a Scientific discipline or health care (preferred).
• Requires 3‑5 years of professional experience in Site Management.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., ICH‑GCP).
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone, and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem‑solving skills.
• High attention to detail and commitment to quality.
Preferred
• Self‑motivated with a strong sense of initiative.
• Adaptability and ability to work in a dynamic environment.
• Collaborative team player with a positive attitude.
• High degree of professionalism and confidentiality.
Compensation and Benefits
• Competitive base salary, bonus, and equity for all employees.
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including…
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Clinical Research Associate (CRA)/ Sr. CRA
Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody‑drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next‑generation biologics from concept to clinic.
This role is based in a remote work setting.
Summary
Fortvita is seeking a dynamic and experienced Clinical Research Associate I or II (CRA) to manage and monitor clinical trial sites to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practices (GCP). This role will play a critical role in driving the success of our clinical trials by supporting site selection, initiation, monitoring, and close‑out activities. The ideal candidate will demonstrate strong attention to detail, effective communication skills, and the ability to work both independently and collaboratively in a fast‑paced environment.
This role is based in a remote work setting.
Responsibilities
• Serve as Study Site Start‑Up activities coordinator in assigned studies for investigative sites, Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines.
• Perform site selection, start‑up, and activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Oversee the progress of clinical studies at assigned sites, ensuring accurate documentation, data integrity, patient safety, and protocol adherence. Review case report forms (CRFs) and source documents.
• Proactively encourage and facilitate site enrollment, helping implement tailored recruitment action plans, and providing motivational feedback and resources to site staff to maintain engagement and momentum in reaching enrollment targets.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Inform team members of the completion of regulatory and contractual documents for individual sites.
• Work with the Project Manager responsible closely for the budget and contract negotiation and sign‑off in a timely manner.
• Provide local expertise to the project team during initial and ongoing project timeline planning.
• Perform quality control of documents provided by sites.
• Maintenance of the eTMF until handed over to the site management team.
• Other duties as assigned.
Qualifications
Required
• Bachelor’s Degree in a Scientific discipline or health care (preferred).
• Requires 3‑5 years of professional experience in Site Management.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., ICH‑GCP).
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone, and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem‑solving skills.
• High attention to detail and commitment to quality.
Preferred
• Self‑motivated with a strong sense of initiative.
• Adaptability and ability to work in a dynamic environment.
• Collaborative team player with a positive attitude.
• High degree of professionalism and confidentiality.
Compensation and Benefits
• Competitive base salary, bonus, and equity for all employees.
• Actual compensation may vary depending on factors such as location, skills, experience, and performance.
• 401(k) retirement plan with employer matching contributions.
• Comprehensive medical, dental, and vision insurance.
• Generous paid time off policy, including…
Apply tot his job
Apply To this Job