[Remote] Clinical Research Associate I or II (CRA)

Note: The job is a remote job and is open to candidates in USA. Fortvita Biologics is a biopharmaceutical company specializing in antibody discovery and engineering, targeting oncology, immunology, and neurodegenerative diseases. They are seeking a Clinical Research Associate I or II (CRA) to manage and monitor clinical trial sites, ensuring compliance with study protocols and regulatory requirements while supporting site selection and trial activities.

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. Skills
• 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.
• 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.

Benefits

• Competitive base salary, bonus, and equity for all employees.
• 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. Company Overview
• It was founded in undefined, and is headquartered in , with a workforce of 51-200 employees. Its website is http://www.fortvitabio.com. Apply To this Job

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