Clinical Research Associate I or II (CRA)
Biolog
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.
Job description
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.
Requirements
- Bachelor's Degree in Scientific discipline or health care preferred
- At least 2 years of professional experience in Site Management
- Good knowledge of applicable clinical research regulatory requirements (i.e., ICH-GCP)
- Proficiency in Microsoft Word, Excel and PowerPoint
- Written and verbal communication skills including good command of English language
- Organizational and problem-solving skills
- High attention to detail and commitment to quality
Benefits
- Bonus
- Equity
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
- Company Holidays
- Floating Holidays
Company overview
Biolog, Inc. is a privately held biotechnology company founded in 1984 and headquartered in Hayward, California. The company specializes in microbial phenotypic characterization and polyphasic identification technologies, providing comprehensive solutions for cellular analysis across research, bioprocess, sustainable agriculture, and diagnostic markets. Biolog's patented technology platform simplifies cell identification and characterization through innovative instrumentation, test panels, and critical software. Their product portfolio includes the Odin system for automated phenotyping, ID Station for microbial identification, anaerobic chambers for oxygen-free work environments, and a wide range of Phenotype MicroArrays for metabolic profiling of microbial and mammalian cells. The company also operates Biolog Lab Services, offering ISO-certified microbial testing, foodborne pathogen detection, and polyphasic identification services from their Newark, Delaware facility. With over 6,600 publications citing their technology and nearly 40 years of experience, Biolog serves customers worldwide through direct sales in the US, Germany, and Austria, complemented by global distribution channels. The company has received significant funding from investors including BroadOak Capital and Research Corporation Technologies, supporting its continued innovation in functional cellular insights.