Clinical Research Coordinator 2 - CRANE Lab

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 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 SPECIFICS:

The CRANE Lab is a multidisciplinary research program focused on cancer prevention and survivorship, lifestyle medicine, behavioral interventions, supportive care, and digital health. Studies are conducted in collaboration with cancer clinics, healthcare providers, and community partners throughout South Florida and involve close interaction with diverse patient populations over extended periods of follow‑up. This individual will join a large multidisciplinary team of researchers and clinicians dedicated to improving the lives of individuals affected by cancer through innovative lifestyle, behavioral, and digital health research. The Clinical Research Coordinator II will serve as a senior member of the Clinic Operations Team, working under the supervision of Grey Freylersythe, Director of Research, and in close collaboration with study investigators, clinical partners, and research leadership. The position ultimately reports to Dr. Tracy Crane, Associate Professor in Medical Oncology, Co-Lead of Cancer Control, and Director of Digital Health and Lifestyle Medicine for Cancer Survivorship. Successful candidates will demonstrate a strong interest in participant-centered research and the ability to build meaningful relationships with participants, caregivers, clinic staff, and research team members. Unlike traditional therapeutic clinical trials that are primarily focused on investigational drugs, devices, and sponsor-driven regulatory activities, many CRANE Lab studies involve intensive participant engagement, behavioral assessment, lifestyle intervention delivery, patient-reported outcomes, and longitudinal participant support. Participants may remain active on study for months or years, requiring coordinators to build trust, maintain engagement, and support retention throughout the research process. Candidates should be comfortable working in highly collaborative, participant-focused environments and possess strong interpersonal, communication, organizational, and problem‑solving skills. The ideal candidate will be motivated by improving the lives of individuals affected by cancer and excited to contribute to research focused on health behaviors, quality of life, symptom management, supportive care, and cancer survivorship. Department Specific Functions Fluent English and Spanish required. Additional language proficiency, including Haitian Creole, is highly desirable. Serve as a senior member of the Clinic Operations Team and provide operational oversight across multiple oncology-focused lifestyle and behavioral research studies. Coordinate and monitor day-to-day study operations to ensure protocol compliance, participant safety, data quality, and adherence to study timelines across multiple active research protocols. Serve as a primary trainer and mentor for Clinical Research Coordinators, Research Support Specialists, students, and other study personnel. Develop, deliver, document, and monitor protocol-specific training, onboarding activities, competency assessments, and retraining initiatives as needed. Conduct routine quality assurance and quality control reviews of study documentation, informed consent forms, source documents, databases, and participant tracking systems. Identify operational issues and implement corrective actions to maintain compliance and data integrity. Assist investigators and research leadership with preparation and maintenance of regulatory documentation, including IRB submissions, continuing reviews, protocol amendments, reportable events, delegation logs, training records, regulatory binders, and sponsor-required documentation. Supervise undergraduate and graduate research assistants supporting study implementation activities, including participant tracking, scheduling, data collection support, and administrative research tasks. Develop and maintain operational reports, enrollment metrics, screening logs, retention reports, workload tracking systems, and quality assurance dashboards. Utilize REDCap, REDCap API integrations, Power BI, Excel, and other reporting tools to support study management and decision-making. Support data management activities including database maintenance, data quality review, query resolution, QA/QC reporting, and implementation of procedures to improve data completeness and accuracy. Serve as a liaison between investigators, clinic staff, participants, interventionists, regulatory personnel, and research team members to facilitate communication, resolve operational issues, and support efficient study execution. Maintain and expand collaborative relationships with cancer clinics, physicians, nurses, and multidisciplinary care teams across Sylvester Comprehensive Cancer Center and affiliated clinical sites. Provide direct participant-facing support as needed, including participant screening, informed consent, data collection visits, administration of questionnaires and physical assessments, wearable device deployment, biospecimen coordination, participant retention activities, and protocol-specific follow-up procedures. Assist Principal Investigators and research leadership with study management activities including protocol implementation, study feasibility assessments, workflow development, literature reviews, manuscript preparation, meeting coordination, and continuous process improvement initiatives. Facilitate specimen collection, processing, shipping, and storage activities according to protocol and regulatory requirements. Oversee compliance with required training programs, including CITI, Good Clinical Practice (GCP), Human Subjects Protection, OSHA requirements, and study-specific competency training. Other duties as assigned. Department Specific Qualifications Education: Bachelor’s degree required Certification and Licensing: Clinical Research Coordinator (CCRC or CCRP) certification preferred Experience: Minimum 2 years research experience in relevant field Experience in behavioral, lifestyle, supportive care, survivorship, public health, prevention, exercise, nutrition, psychosocial, or digital health research strongly preferred. Experience conducting participant interviews, administering questionnaires, collecting patient-reported outcomes, or coordinating longitudinal observational studies preferred. Demonstrated experience building rapport with diverse participant populations and supporting long‑term participant retention efforts preferred. Experience team leadership, training, supervising, or mentoring others is strongly preferred. Experience with REDCap database development and management, including REDCap API integrations, reporting tools, Power BI, or data visualization platforms, strongly preferred. Knowledge, Skills and Attitudes: Demonstrated leadership and project coordination skills. Strong understanding of human subjects research regulations and Good Clinical Practice. Excellent organizational, communication, and problem‑solving skills. Ability to identify operational challenges and implement process improvements. Strong analytical and reporting skills. Ability to manage multiple protocols simultaneously while maintaining attention to detail. Ability to work independently and exercise sound judgment.

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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 #J-18808-Ljbffr University of Miami