BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Life Sciences community. We are currently looking for an REMOTE (East Coast-based) Clinical Research Associate for a leading San Diego area pharma company.
*Must be local and willing to travel to East Coast sites
Responsibilities
- Conduct remote and on-site monitoring visits (qualification, initiation, interim, and close-out) to ensure protocol adherence, subject safety, and data integrity.
- Build and maintain collaborative relationships with clinical site staff to support site performance and engagement throughout the study lifecycle.
- Review source documents, case report forms (CRFs), and informed consent forms for accuracy, completeness, and compliance with GCP and protocol requirements.
- Monitor investigational product handling, including receipt, storage, administration, reconciliation, and return.
- Collect, review, and track essential regulatory documents; ensure timely updates and filing in the electronic Trial Master File (eTMF).
- Support site selection, qualification, and activation activities in collaboration with the clinical study team.
- Track subject visits and enrollment progress; maintain up-to-date records in the Clinical Trial Management System (CTMS) and related platforms.
- Assist in resolving protocol deviations, data queries, and operational issues; escalate site concerns in alignment with study guidelines.
- Train and support site personnel on study protocols, data collection tools, and regulatory expectations.
- Contribute to site-level recruitment efforts and recommend strategies to enhance site performance and enrollment.
- Complete required administrative tasks and study trainings in a timely and organized manner.
- Participate in initiatives to optimize clinical monitoring processes and support high-quality trial execution.
Qualifications
- Bachelor’s degree in life sciences, healthcare, or a related field.
- Minimum 5 years of experience as a Clinical Research Associate or in a clinical monitoring capacity.
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes.
- Proven ability to conduct qualification, initiation, monitoring, and close-out visits independently.
- Skilled in reviewing source data, case report forms (CRFs), and essential regulatory documents for accuracy and protocol compliance.
- Experience managing investigational product accountability and site-level documentation.
- Proficient in clinical systems including CTMS, eTMF, and electronic data capture platforms.
- Excellent attention to detail with strong organizational and documentation skills.
- Clear and professional communicator, effective in both written reports and verbal site interactions.
- Capable of independently managing timelines, prioritizing tasks, and supporting multiple sites or studies.
- Familiarity with various therapeutic areas and comfortable working across different study phases.
- Prior exposure to risk-based monitoring models or CRO oversight is preferred.
*Travel up to 75% may be required.
What we offer:
As we work to develop innovations that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
· Full support and career-development resources to help you reach your potential
· A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Apply now and let's make work better!
www.biophaseinc.com