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About the Role
The Clinical Research Coordinator will manage the day-to-day operations of assigned clinical trials, ensuring adherence to protocols and regulatory requirements. This role involves recruiting and screening participants, documenting study operations, and reporting on participant status. The position requires strong communication, organizational, and problem-solving skills to manage priorities effectively and ensure high-quality participant care.
Responsibilities
- Exercise judgment within defined limits for clinical trial protocols, SOPs, and directives from leadership.
- Maintain participant privacy and data confidentiality, complying with FDA, ICH GCP, HIPAA, IRB, and institutional policies.
- Complete study-directed assessments with participants, including informed consent, medical history, adverse events, Fibroscan, memory screens, and vital signs collection.
- Complete documentation and data management tasks in accordance with GCP and regulatory guidelines.
- Act as a liaison with pharmaceutical sponsors and external vendors, participating in monitoring visits and audits.
- Manage participant engagement from recruitment through study completion.
- Respond promptly to internal and external requests for information.
- Identify opportunities to improve participant care and satisfaction.
- Resolve study-related challenges collaboratively and with a solutions-oriented mindset.
- Establish and maintain productive relationships with internal and external personnel.
- Coordinate multiple projects with competing priorities and deadlines.
- Attend investigator's meetings, pre-study site visits, study initiation visits, and other sponsor-related visits.
- Track enrollment status reports to ensure study sites meet enrollment goals.
- Track study-specific status reports to maintain current information on site issues, deviations, and CRF status.
- Create memos, emails, and letters related to study activities.
- Create and maintain reports and/or spreadsheets.
- Assist regulatory personnel with study documents and ensure proper saving and uploading of electronic regulatory documents.
- Report safety information to regulatory agencies.
- Perform quality checks on study-specific source documents.
- Assist with the Corrective and Preventive Action Plan (CAPA) process.
Requirements
- High school diploma or GED required.
- Bachelor’s Degree in a scientific area of study preferred or equivalent combination of education, training, and experience.
- 1 year of experience as a Clinical Research Assistant or Coordinator.
- 1-2 years of experience in Clinical Research.
- Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS.
- Strong knowledge of ICH/GCP guidelines.
- Must complete GCP training before interacting with participants and recertify every 2 years or as applicable.
- Trained and certified in the administration of Fibroscan and memory screens as required by the study portfolio and individual experience (training to be provided).
- Basic life support (BLS) training required (provided during onboarding).
- Demonstrated organizational skills and outstanding time management, with keen attention to detail and the ability to track multiple projects.
- Strong written and oral communication skills.
- Knowledge of basic medical terminology.
- Possess impeccable integrity and personal and professional values consistent with company standards and mission.
- Comply with company policies, code of ethics, and guiding values.
- Proficient in Spanish and English preferred.
- Valid Driver’s License.
- Ability to effectively communicate with all levels of internal and external contacts.
- Demonstrated ability to manage a high-volume workload with multiple clinical trials while maintaining accuracy and compliance.
- Ability to work independently and multitask in a fast-paced team environment.
- Strong people skills, including the ability to interact with individuals from diverse backgrounds and oversee confidential matters with discretion.
- Positive, friendly, and professional demeanor, especially when interacting with research participants.
- Ability to work independently and collaborate with a team.
- Ability to interpret clinical research protocols.
- Strong problem-solving and decision-making skills, particularly under pressure.
- Proactive at identifying, addressing, and solving issues in real time.
- Energetic self-starter, results-oriented, and able to work effectively in an entrepreneurial environment.
- Work is performed in an office/laboratory and/or a clinical environment.
- Exposure to biological fluids and/or bloodborne pathogens.
- Personal protective equipment is required.
- Occasional travel may be required, domestic and/or international.
- Ability to work in an upright and/or stationary position for 6-10 hours per day.
- Frequent mobility required.
- Occasional squatting, kneeling, or bending.
- Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.
Skills
- Communication
- Organizational skills
- Problem-solving
- Multi-tasking
- Detail-oriented
- Participant care
- Collaboration
- Goal-oriented
- Flexibility
- Responsiveness
- Thoughtfulness
- Empathy
- Initiative-taking
- Team player
- Project management
- Time management
- Microsoft Office Suite
- Clinical Research IO (CRIO)
- ICH/GCP guidelines
- Medical terminology
- Spanish proficiency
- English proficiency
- Independent work
- Team collaboration
- Protocol interpretation
- Decision-making
- Proactive issue identification
- Self-starter
- Results-oriented
Location
- Onsite
Work Type
- Full-time
Experience Level
- 1 year of experience as a Clinical Research Assistant or Coordinator
- 1-2 years of experience in Clinical Research
Education Level
- High school diploma or GED
- Bachelor’s Degree in a scientific area of study preferred