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.


CORE JOB SUMMARY


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.


CORE JOB FUNCTIONS

• 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.

CORE QUALIFICATIONS


Education:


Bachelor's degree in relevant field required


Experience:


Minimum 2 years of relevant experience


Knowledge, Skills and Attitudes:

• 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.

Department Addendum:

Career Stage: Intermediate

• Coordinates and independently manages assigned routine-to-moderately complex studies within delegated authority, with access to leadership for complex or higher-risk matters. Routine-to-moderately complex studies are those with a single site, established procedures, industry sponsorship with active monitoring, or multi-arm designs not involving investigational devices or first-in-human elements. Studies meeting CRC 3 portfolio thresholds - as defined in the CTRS Study Complexity Matrix - are assigned with CRC Supervisor co-oversight or leadership.

Department-Specific Functions

• 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.

Professional Progression and Readiness

• 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.

Department-Specific Qualifications

• 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.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status:
Full time

Employee Type:
Staff