Clinical Research Coordinator 2

University of Miami•Miami, FL

22h•Onsite

About The Position

The Department of Clinical Translational Research Site, Otolaryngology is currently seeking a full-time Clinical Research Coordinator to work in Miami. The Clinical Research Coordinator serves as an mid-level research professional with experience in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.

Requirements

Bachelor’s degree in relevant field
Minimum 3 year of relevant experience
Skill in completing assignments accurately and with attention to detail.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Commitment to the University’s core values.
Ability to work independently and/or in a collaborative environment.
Demonstrated knowledge of ICH GCP, IRB and FDA clinical research requirements, HIPAA/privacy, safety reporting obligations, and essential document standards, verified through current CITI certification (GCP and Human Subjects tracks, renewed per institutional schedule) and observed independent performance on assigned studies.
Proficiency in source documentation, ALCOA+ principles, EDC/CRF completion, query resolution, regulatory file maintenance, and research systems. Demonstrated independent proficiency across all assigned research systems.
Ability to identify risk, analyze recurring problems, support corrective actions, and communicate clearly with the PI and leadership.

Nice To Haves

Actively pursuing ACRP (CCRC/ACRP-CP) or SOCRA (CCRP) certification is expected at this level. CRC 2 coordinators are encouraged to obtain certification no later than Year 2 in the role to maintain eligibility for CRC 3 advancement consideration.

Responsibilities

Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
Knows the contents and maintenance of study-specific clinical research regulatory binders.
Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Adheres to University and unit-level policies and procedures and safeguards University assets.
Coordinates and independently manages assigned routine-to-moderately complex studies within delegated authority, with access to leadership for complex or higher-risk matters.
Independently coordinates priorities, timelines, and communications across multiple assigned studies and/or Principal Investigator teams.
Serves as a routine day-to-day contact for assigned studies. Communicates protocol and participant-specific decisions directly to the PI; routes operational, regulatory, and risk matters to the supervising CRC or CRC Manager per the CTRS Escalation and Decision Authority Matrix.
Exercises judgment within approved protocols, SOPs, delegation, sponsor requirements, and institutional requirements and escalates higher-risk or ambiguous matters.
Provides protocol-specific coaching and orientation to CRC 1 staff within their assigned areas of competency; documents training activities in the delegation log or CTRS training record system.
Supports sponsor monitoring visit preparation, participates in visit response and follow-up, and tracks assigned action items through resolution.
Demonstrates sustained independent coordination of assigned studies, including participant, data, regulatory, monitoring, and close-out responsibilities.
Identifies recurring issues and documents them for the supervising CRC or CRC Manager, who leads corrective action planning. CRC 2 implements assigned corrective steps within their own portfolio and reports completion.
Demonstrates effective stakeholder communication, reliable judgment, peer support, and readiness for advanced study and portfolio leadership.