Clinical Research Coordinator II
About The Position
The Clinical Research Coordinator II (CRC II) ensures high-quality research at assigned investigative sites in accordance with sponsor protocols, FDA regulations, and ICH/GCP guidelines, while providing quality data to sponsors and helping meet or exceed study enrollment expectations. The role supports timely achievement of company goals and works under the direction of the Site/Study Management Team for assigned protocols. The CRC II conducts study visits and protocol-required procedures, maintains accurate and timely clinical-trial documentation and data, supports recruitment and retention, and coordinates with research participants, investigators, sponsors, CROs, laboratory staff, data teams, and administrative staff. The position also supports site and study readiness, safety reporting, and adherence to applicable protocols, regulations, and organizational procedures.
Requirements
- At least 2 years of experience as a clinical research coordinator.
- High school diploma or equivalent.
- Strong verbal and written English communication and comprehension skills.
- Ability to work energetically, take initiative, pay attention to detail, and multitask.
- Ability to pursue goals while maintaining quality.
Nice To Haves
- Bachelor's degree.
- Foreign medical graduate background.
- Experience coordinating industry-sponsored vaccine studies, preferably in a private setting.
- ACRP or equivalent certification.
- Bilingual English/Spanish verbal and written communication and comprehension skills.
Responsibilities
- Complete required company training, including ICH-GCP and IATA certifications, and complete study-specific training before study start and on an ongoing basis.
- Conduct study-subject visits and other protocol-required procedures, documenting them in a timely manner.
- Maintain clinical-trial documentation in accordance with ALCOA-C standards.
- Complete data entry and resolve queries within internal company timelines and sponsor expectations.
- Follow up appropriately and promptly on site action items.
- Implement laboratory manuals and protocol-specified laboratory procedures, including storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team.
- Coordinate with laboratory and data teams, administrative staff, clinical investigators, research participants, and sponsor/CRO representatives for assigned protocols.
- Adhere to assigned protocols and maintain working knowledge of FDA regulations, ICH-GCP guidelines, organizational SOPs, guidance documents, and study protocols.
- Maintain working knowledge of recruitment and retention processes for assigned protocols.
- Prepare for sponsor and CRO visits and maintain current versions of study protocols, informed consents, manuals, and other relevant study documents.
- Oversee reporting of adverse events, serious adverse events, and other relevant safety information to appropriate authorities in accordance with company guidelines, sponsor requirements, IRB requirements, and ICH-GCP guidelines.
- Work toward sponsor subject-enrollment goals for assigned protocols.
- Attend required company meetings and submit administrative paperwork within company timelines.
- Occasionally attend out-of-town Investigator Meetings.
- Conduct patient consent discussions and ensure patients understand medical procedures, risks, benefits, and alternatives.
- Explain study protocols clearly and ensure patients understand them before obtaining consent.
- Facilitate communication among patients, healthcare providers, and research staff.
- Perform other duties as assigned by management.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
