Sr. CRA

Location:

Remote - Hiring in these states: FL, MN, NC, NJ, NY, PA, TX, VA

Preference for FL & NC

Travel up to 50% required

ABOUT THE COMPANY

Fortvita Biologics is a San Francisco Bay Area-based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden.

Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.

Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.

POSITION SUMMARY

The Sr. Clinical Research Associate (CRA) is responsible for managing and monitoring clinical trial sites to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practices (GCP). This position 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 primarily remote work setting, with travel to clinical sites as required.

ESSENTIAL FUNCTIONS AND 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 closely with the Project Manager responsible 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 for the site related documents until handed over to the site management team.
• Other duties as assigned

REQUIRED QUALIFICATIONS

• Bachelor's Degree: in Scientific discipline or health care preferred.
• Experience: Requires 4-7 years of professional experience in Site Management.
• Knowledge: Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., ICH-GCP).
• Computer skills: include proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone, and iPad (where applicable).
• Communication skills: Written and verbal communication skills including good command of English language.

PREFERRED QUALIFICATIONS

• Oncology Clinical Trials: experience is preferred.
• Prior involvement: in site start-up and contract/budget coordination preferred.

Competencies / Core Skills

• Self-motivated with a strong sense of initiative.
• High attention to detail and commitment to quality.
• Strong communication and interpersonal skills, including site and PI engagement.
• Ability to build and maintain effective site relationships.
• Strong organizational and time management skills.
• Problem-solving and critical thinking abilities.
• Adaptability and ability to work in a dynamic environment.
• Collaborative team player with a positive attitude.
• High degree of professionalism and confidentiality.

COMPENSATION

The base salary range: for this position is $115,000.00 to $130,000.00/year. Actual starting pay is determined based on the candidate's years of relevant experience, educational background, and demonstrated skills.

Equal Opportunity Employer Statement

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.