Clinical Research Coordinator

MISSION STATEMENT: The Cardiovascular Institute of San Diego (CVISD) goal and mission is to provide comprehensive cardiovascular services that provide exemplary care to patients in our community. We provide the highest standard of care with emphasis on communication, empathy and convenience to our patients.

SUMMARY: The Clinical Research Coordinator (CRC) is under the direct supervision of the Clinical Trials Manager. The CRC is responsible for conducting and assisting in clinical research studies, obtaining informed consent, collecting, maintaining and organizing study information for the Cardiology Research Unit (CRU) at CVISD. Serves as a liaison between the organization, investigators, and the research sponsors. Responsible for planning, implementation and oversight of a variety of clinical trials, maintains compliance with all applicable institutional, state and federal regulations in collaboration with investigator. Performs independently to coordinate all aspects of clinical research projects including administrative functions and clinical functions per scope of practice. Other responsibilities include recruiting, retaining, motivating and educating research patients in clinical trials, training other research personnel in research procedures, and tracking patient enrollment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Coordinate and manage daily operations of clinical research studies in accordance with study protocols and regulatory guidelines.

2. Perform phlebotomy on study participants following established protocols.

3. Process, label, and transport biological samples per study-specific requirements (e.g., centrifugation, storage, shipping).

4. Recruit and screen study participants, obtain informed consent, and maintain participant confidentiality.

5. Schedule and conduct participant visits, including administering questionnaires and collecting vital signs.

6. Maintain accurate study documentation, including case report forms, lab logs, and source documentation.

7. Ensure that all study documents are accurately completed and filed in a timely manner, including maintaining documents required for the regulatory binder, investigative drug binder, and any other document repositories required by the principal investigator or regulatory entities.

8. Coordinate, implement, and manage procedures to collect data from patient charts, medical records, prescreening interviews, questionnaires, diagnostic tests, and other sources.

9. Ensure compliance with IRB, HIPAA, GCP, and institutional policies.

10. Assist in the preparation and submission of regulatory documents including IRB applications and study reports.

11. Collaborate with investigators, sponsors, and laboratory personnel to ensure study timelines and quality standards are met.

12. Support data entry and database management.

13. Maintain accurate and complete records of study procedures and data.

14. Attend study team meetings and provide updates on study progress.

15. Provide oversight and training to research assistants or interns involved in specimen handling or data collection.

16. Follow protocol guidelines in the collection of clinical data and/or administration of clinical tests.

17. Perform other research-related duties as assigned by the principal investigator or Clinical Trials Manager.

18. Assure compliance of general and study-specific regulatory-related processes with ICH, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.

OB REQUIREMENTS:

The requirements listed are representative of the knowledge, skills, minimum education, training, licensure, experience, and/or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Excellent written and verbal communication skills with ability to manage independent projects and meet deadlines required.
Excellent organizational and communication skills are required.
Demonstrated computer skills with Microsoft Office applications.
Bilingual required (Spanish speaking).
Phlebotomy certificate preferred* EDUCATION AND/OR EXPERIENCE:
Bachelor’s Degree in a relevant science plus at least three (3-5) years of related clinical research experience ·
Association of Clinical Research Profession (ACRP) or SOCRA certification (or willingness to obtain within 1 year of hire)
3-5 years of experience in a clinical setting
Phlebotomy certificate preferred
Knowledge of Good Clinical Practice (GCP) and ICH guidelines ·
Strong organizational and time management skills and ability to multitask and work well under pressure.
Must work and communicate effectively with both internal and external team members.
Ability to maintain confidentiality and work with sensitive information.

ENVIRONMENT: This position requires standing for extended periods of time, as well as the ability to lift up to 25 pounds.

Job Type: Full-time

Pay: From $72,000.00 per year

Benefits: