Clinical Research Coordinator II - CRANE Lab

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The SCCC department has an exciting opportunity for a Clinical Research Coordinator 2 the CRC2 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.

Primary Responsibilities:

• 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.

Additional Responsibilities:

• Bilingual in English and Spanish required.
• Assist the study investigators and work collaboratively in the preparation of IRB, NIH and other organization regulatory compliance reports.
• Supervise a team of undergraduate and graduate research assistants in the support of study activities
• Perform study-related tasks including participant recruitment and scheduling, administration of all measures, screening tools, intervention operationalization, and lead retention efforts.
• Maintain and expand collaborative relationships with cancer clinics, physicians, and nurses and Sylvester Comprehensive Cancer Clinic.
• Provide research support to Principal Investigators assisting with maintenance of databases, coordinating weekly research meetings, assisting with literature reviews/searches and manuscript preparation.
• Facilitate sample collection, processing and storage.
• Oversee CITI-training in the Protection of Human Participants and OSHA-mandated training related to the handling of physiological specimens. 
• Other duties as assigned.

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 experie