Clinical Research Coordinator 2

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The Department of the Clinical Translational Research Site has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work on-site at the Don Soffer Clinical Research Center in Miami, FL.

The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel. 

• Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility. 

• Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols. 

• Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations. 

• Maintains study binders and filings according to protocol requirements, UM and department policy. 

• Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator. 

• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations. 

• Assists in implementing protocol amendments under direct supervision of the Principal Investigator. 

• Assists with study orientation and protocol related in-services to research team and clinical staff. 

• Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule. 

• Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments. 

• Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews. 

• Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc. 

• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies. 

• 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.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
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• 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. Certification is required at the CRC 3 level; coordinators who have not yet obtained it will not meet the CRC 3 Core Qualification threshold regardless of performance. 

• 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. 

Bachelor’s degree in relevant field required 

Minimum 2 years 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. 

• 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. Higher-risk matters requiring escalation to the CRC Supervisor or CRC Manager include: protocol deviations involving participant safety, consent process failures, out-of-window critical assessments, any adverse event requiring expedited reporting, and sponsor or IRB communications involving regulatory action. 

• 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. Does not conduct formal performance evaluations of CRC 1 staff unless the CRC Manager delegates that responsibility in writing. 

• Supports sponsor monitoring visit preparation, participates in visit response and follow-up, and tracks assigned action items through resolution. 

• Escalation of study, regulatory, and participant-safety matters follows the CTRS Escalation and Decision Authority Matrix. 

• 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. 

• Advancement is based on demonstrated competency, performance, study complexity, increased responsibility, professional development, and organizational need; experience alone does not guarantee promotion. Advancement consideration also includes progress toward the CRC 2 certification expectation and readiness for CRC 3 responsibilities.