Apply on Employer Site

Fortvita Biologics · 4 weeks ago

Clinical Research Associate I or II (CRA)

United States

Full-time

Remote

Entry, Mid Level

2+ years exp

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.

Biotechnology

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

Qualification

Clinical research regulationsSite management experienceMicrosoft Office proficiencyBachelor’s Degree in ScienceWritten communication skillsVerbal communication skillsOrganizational skillsProblem-solving skillsAttention to detailTeam collaborationAdaptability

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