Clinova Pro Services

We are seeking a Clinical Research Coordinator (CRC) to join our clinical research team and support the successful execution of clinical trials from study start-up through completion.

The Clinical Research Coordinator plays a key role in coordinating study activities, supporting participant recruitment and retention, conducting protocol-required visits and procedures, maintaining accurate study documentation, managing clinical data, and ensuring studies are conducted in accordance with the protocol, Good Clinical Practice (GCP), applicable regulations, and site Standard Operating Procedures (SOPs).

This position is ideal for a detail-oriented, organized, and compassionate clinical research professional who enjoys working directly with study participants while collaborating with Investigators, Sponsors, CROs, and a multidisciplinary research team.

Essential Job Functions:

• Coordinate the day-to-day activities of assigned clinical research studies.
• Review study protocols and complete all required Sponsor and site training.
• Participate in Investigator Meetings, Site Initiation Visits, study trainings, and other Sponsor-required meetings.
• Coordinate study start-up activities, including staff training, system access, study supplies, laboratory requirements, and other site readiness activities.
• Obtain informed consent from study participants in accordance with the protocol, GCP, and site SOPs.
• Coordinate and conduct participant study visits within protocol-defined visit windows.
• Perform protocol-required clinical research procedures within the scope of training, delegation, and applicable regulations.
• Support participant recruitment, enrollment, engagement, and retention efforts.
• Maintain professional and ongoing communication with study participants and address questions or concerns throughout their participation.
• Ensure participant data and study documentation are accurate, complete, and maintained in a timely manner.
• Enter study data into Electronic Data Capture (EDC) systems within required timelines.
• Track participant status, visit schedules, follow-up activities, and study milestones.
• Identify, document, and appropriately escalate Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, and other study-related issues.
• Coordinate laboratory requirements, including specimen collection, processing, storage, packaging, and shipment in accordance with the protocol and laboratory manual.
• Maintain essential study and regulatory documentation as required.
• Assist CRAs, Sponsors, CROs, auditors, and other authorized personnel during monitoring visits, audits, and inspections.
• Respond to data queries and assist with timely resolution of monitoring findings and action items.
• Communicate regularly with the Principal Investigator, Managers, and other site departments regarding study progress and issues.
• Support achievement of study enrollment and retention goals while maintaining participant safety, data integrity, and protocol compliance.
• Perform additional study-specific responsibilities as required by the protocol, Sponsor, Investigator, or site leadership.
• The Clinical Research Coordinator reports to the Site Director.

Required Qualifications:

• 3+ years of clinical research experience, preferably in a clinical research site environment.
• Strong working knowledge of clinical research processes and ICH-GCP.
• Understanding of clinical research regulatory and documentation requirements.
• Knowledge of HIPAA and participant confidentiality requirements.
• Strong clinical terminology knowledge.
• Excellent verbal and written communication skills.
• Exceptional attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Strong interpersonal and problem-solving skills.
• Ability to work independently while contributing effectively to a multidisciplinary team.
• Proficiency with Microsoft Office 365 and the ability to learn clinical research systems and electronic platforms.
• Bilingual English/Spanish proficiency required.
• Ability to work occasional evenings, weekends, or extended hours when required by study activities.

Education & Experience:

• Associate degree or equivalent education/experience required.
• Bachelor's degree in a related field preferred.
• Candidates with backgrounds as a Foreign Medical Graduate (FMG), Registered Nurse (RN), Registered Medical Assistant (RMA), Certified Medical Assistant (CMA), or other relevant healthcare professional are encouraged to apply.
• Clinical research certification such as CCRC is preferred.

Preferred Experience:

• Experience coordinating multiple clinical trials.
• Experience with EDC, CTMS, eRegulatory, eTMF, or other clinical research technology platforms.
• Experience with participant recruitment and retention.
• Experience working with pharmaceutical, biotechnology, CRO, or clinical research site organizations.
• Experience supporting Sponsor monitoring visits, audits, or regulatory inspections.

We are an Equal Employment Opportunity employer committed to a workplace free from discrimination and harassment. We prohibit discrimination based on age, race, color, sex, pregnancy, gender identity or expression, sexual orientation, national origin, religion, marital status, citizenship, disability, veteran status, or any other status protected by applicable federal, state, or local law.

Pay: $25.00 - $30.00 per hour

Expected hours: 40.0 per week

Work Location: In person