Clinical Research Coordinator

Division: allied research institute
Reports To: Vice President of Research

Employment Type: Independent Contractor

Position Summary

The Clinical Research Coordinator is responsible for supporting the day-to-day implementation and management of clinical research studies, including clinical trials, observational studies, and patient-centered research projects. This role coordinates participant recruitment, informed consent, study visits, data collection, regulatory documentation, and communication among the research team, clinical staff, sponsors, investigators, and participants.

The Clinical Research Coordinator ensures that all research activities are conducted in accordance with the approved protocol, Good Clinical Practice standards, organizational policies, sponsor requirements, and applicable federal, state, and institutional regulations.

Essential Duties and Responsibilities

Study Coordination and Implementation

• Coordinate daily operations for assigned clinical research studies and trials.

• Review study protocols and assist in developing study workflows, visit schedules, and implementation plans.

• Organize and track study timelines, enrollment goals, visit windows, deliverables, and study milestones.

• Coordinate study start-up activities, including training, documentation, and site readiness.

• Support study closeout activities, including final documentation, data reconciliation, and sponsor/regulatory follow-up.

Participant Recruitment and Enrollment

• Assist with identifying potential study participants through approved recruitment strategies.

• Screen potential participants for study eligibility based on protocol inclusion and exclusion criteria.

• Coordinate outreach, scheduling, follow-up, and reminders for study participants.

• Conduct or support the informed consent process, as permitted by organizational policy and protocol requirements.

• Maintain participant confidentiality and ensure all recruitment and consent activities are properly documented.

Study Visits and Participant Follow-Up

• Coordinate participant study visits in collaboration with clinical providers, nurses, research staff, and external partners.

• Collect study-related information, questionnaires, forms, and source documents.

• Ensure required study procedures are completed according to the protocol and within required timeframes.

• Track missed visits, rescheduled visits, participant withdrawals, and follow-up needs.

• Serve as a primary point of contact for study participants and respond to routine study-related questions.

Data Collection and Documentation

• Collect, enter, and maintain accurate study data in electronic data capture systems, spreadsheets, databases, or sponsor platforms.

• Ensure completeness, accuracy, and timeliness of source documentation and case report forms.

• Review study records for missing, inconsistent, or incomplete data.

• Assist with query resolution and data clarification requests.

• Maintain organized study files, participant logs, screening logs, enrollment logs, and visit tracking tools.

Regulatory and Compliance Support

• Maintain study records in accordance with regulatory, sponsor, IRB, and organizational requirements.

• Assist with preparation of IRB submissions, continuing reviews, amendments, reportable events, and study closeout documentation.

• Track required staff training, delegation of authority logs, protocol signatures, and essential regulatory documents.

• Report protocol deviations, adverse events, and participant safety concerns to the appropriate supervisor, investigator, or regulatory team.

• Support audit readiness and participate in sponsor, IRB, or internal monitoring visits.

Communication and Team Collaboration

• Communicate regularly with investigators, sponsors, monitors, clinical teams, community partners, and internal leadership.

• Participate in study team meetings, site initiation visits, monitoring visits, and sponsor calls.

• Prepare meeting notes, updates, trackers, and reports related to study progress.

• Work collaboratively with clinical operations, quality, compliance, finance, and data teams as needed.

• Help ensure that research activities are integrated into clinical workflows with minimal disruption to patient care.

Required Qualifications

• Bachelor’s degree or Masters Degree in public health, health sciences, nursing, social work, psychology, biology, healthcare administration, or related field preferred.

• Prior experience in clinical research, healthcare, community health, public health, or patient navigation preferred.

• Familiarity with clinical research protocols, informed consent, data collection, and participant tracking.

• Strong organizational skills and attention to detail.

• Ability to manage multiple tasks, timelines, and study requirements.

• Excellent communication and interpersonal skills.

• Ability to work with diverse patient populations in a culturally respectful manner.

• Proficiency with Microsoft Office, electronic health records, spreadsheets, and data entry systems.

Preferred Qualifications

• Experience working in a Federally Qualified Health Center, academic medical center, or community-based research setting.

• Knowledge of Good Clinical Practice, human subjects protections, HIPAA, and IRB processes.

• Experience with electronic data capture systems such as REDCap, Medidata, Florence, or similar platforms.

• Bilingual ability preferred, depending on patient population.

• Clinical Research Coordinator certification preferred but not required.

Key Competencies

• Strong attention to detail

• Ethical judgment and confidentiality

• Time management and follow-through

• Protocol adherence

• Cultural humility

• Team collaboration

• Problem-solving

Organizational Expectations

All employees are expected to:

• Uphold the organization’s mission, values, and commitment to ethical research.

• Protect the rights, safety, dignity, and confidentiality of research participants.

• Work respectfully with diverse communities, patients, staff, investigators, and external partners.

• Follow all applicable organizational policies, research protocols, regulatory requirements, and compliance standards.

• Maintain accurate documentation and timely communication.

• Participate in training, team meetings, quality improvement activities, and performance review processes.

• Support a culture of accountability, transparency, collaboration, and continuous learning.

Work Environment

This position may require work in a clinical, office, hybrid, or community-based setting. The role may involve interaction with patients, research participants, clinical staff, investigators, sponsors, monitors, and community partners. Some local travel, evening hours, or flexible scheduling may be required depending on study needs.

Equal Employment Opportunity Statement

The organization is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected status under applicable law.