Clinical Research Associate

BioPhase; United States; Remote; USD 100,000 - 125,000; Full time

Job summary

BioPhase is seeking a Clinical Research Associate to join a leading pharma company based in San Diego, focused on drug development in the Life Sciences sector. The role involves extensive monitoring, compliance verification, and collaboration with clinical site staff, demanding strong attention to regulatory detail. This exciting opportunity offers competitive compensation and a chance to grow professionally in a supportive environment.

Benefits

401(k)

Medical insurance

Vision insurance

Qualifications

• Minimum 5 years as Clinical Research Associate.
• Strong knowledge of ICH-GCP and FDA regulations.
• Proven ability to conduct independent monitoring visits.

Responsibilities

• Conduct remote and on-site monitoring visits.
• Review source documents and ensure compliance.
• Support site selection and maintain records in CTMS.

Skills

Knowledge of ICH-GCP

Clinical trial processes

Attention to detail

Communication

Organizational skills

Education

Bachelor’s degree in life sciences

Tools

CTMS

eTMF

Job description

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This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100,000.00/yr - $125,000.00/yr

Additional compensation types

Annual Bonus

Direct message the job poster from BioPhase

Senior HR & Admin Recruiter @ BioPhase | Life Sciences

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!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

401(k)

Vision insurance

Medical insurance

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