Clinical Research Associate I or II (CRA)

Fortvita Biologics; United States; Remote; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive base salary

Bonus

Equity

401(k) retirement plan with employer

Medical, dental, and vision insurance

Generous paid time off

Job summary

Fortvita Biologics is seeking a dynamic and experienced Clinical Research Associate I or II (CRA) to monitor clinical trial sites, ensure GCP compliance, and support site selection, initiation, monitoring, and close-out activities. This remote role requires strong attention to detail and effective communication within a fast-paced environment.

The ideal candidate will have a scientific/healthcare background, 2+ years in Site Management, and proficiency with regulatory requirements and MS Office.

Qualifications

• Bachelor’s Degree in Scientific discipline or health care preferred.
• Requires at least 2 years of professional experience in Site Management.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (ICH-GCP).
• Computer skills including proficiency in Word, Excel and PowerPoint and use of a laptop.
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• High attention to detail and commitment to quality.

Responsibilities

• Serve as Study Site Start-Up activities coordinator for investigative sites and other departments.
• Perform site selection, start-up, and activation activities per regulations and SOPs.
• Prepare site regulatory documents with completeness and accuracy.
• Oversee progress of clinical studies at sites with data integrity and safety.
• Encourage site enrollment and support recruitment plans.
• Maintain internal systems and project trackers with site data.
• Provide feedback on site performance metrics to management.
• Coordinate with budget and contract teams for timely sign-off.
• Offer local expertise to project planning and timelines.
• Perform quality control of documents from sites.
• Maintain the eTMF until handover to site management.

Skills

Site management

Regulatory knowledge

Communication skills

English proficiency

Attention to detail

Education

Bachelor’s Degree in Scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop

Job description

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

• Under general supervision, 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 Scientific discipline or health care preferred.
• Requires at least 2 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 Include:

• 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 company holidays and floating holidays.

Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.

We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.

Additional Legal Disclaimers

Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.

Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.

Reasonable accommodation:

If you require reasonable accommodation during the application process, please contact Fortvita’s Human Resources team at [e-mail]. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.