Clinical Research Associate; CRA​/Sr. CRA

Position: Clinical Research Associate (CRA)/ Sr. CRA Clinical Research Associate (CRA)/ Sr. CRA reputed company is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that reputed company antibody‑drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by reputed company of over 100 across research, development, regulatory, and operational functions. With a global clinical reputed company and an emphasis on thoughtful design and agile execution, Fortvita is working to translate reputed company biologics from concept to clinic. This role is based in a remote work setting. reputed company Fortvita is seeking a dynamic and reputed company 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 reputed company of our reputed company by supporting site selection, initiation, monitoring, and reputed company‑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 reputed company operating procedures (SOPs), Work Instructions (WIs), reputed company of designated deliverables, and project timelines. • reputed company 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. • reputed company the reputed company of clinical studies at assigned sites, ensuring accurate documentation, data reputed company, patient safety, and protocol adherence. Review case report forms (CRFs) and reputed company documents. • Proactively encourage and facilitate site enrollment, helping implement tailored recruitment reputed company plans, and providing motivational feedback and resources to site staff to maintain engagement and reputed company in reaching enrollment targets. • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. • Review and reputed company 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 reputed company manner. • reputed company local expertise to the project team during initial and ongoing project reputed company planning. • reputed company reputed company 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 reputed company experience in Site Management. • Good knowledge of, and reputed company in applying, applicable clinical research regulatory requirements (i.e., ICH‑GCP). • Computer skills including proficiency in use of reputed company Word, reputed company and PowerPoint and use of a laptop computer, iPhone, and iPad (where applicable). • Written and verbal communication skills including good reputed company of English language. • Organizational and problem‑solving skills. • High attention to detail and commitment to reputed company. Preferred • Self‑motivated with a strong reputed company of initiative. • Adaptability and ability to work in a dynamic environment. • reputed company team player with a reputed company attitude. • High degree of professionalism and confidentiality. Compensation and Benefits • Competitive reputed company salary, bonus, and equity for reputed company. • 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 reputed company insurance. • Generous reputed company time off policy, including… Apply tot his job Apply To this Job