Clinical Research Coordinator 2

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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. The Clinical Research Coordinator 2 will work within the Division of Digestive Health and Liver Diseases, but will be responsible for working with Investigators in other divisions on collaborative sponsored research studies. This will include all aspects of coordinating a clinical research trial in terms of regulatory reporting, assisting with medication dispensing from the investigational pharmacy, and helping to process and ship specimens. Candidate will be expected to meet with study monitors and maintain all regulatory documents. Hours may fluctuate depending on clinic and procedure days; therefore, candidate must be flexible in hours. In addition, the candidate will be involved in other clinical research studies across campus, and assisting with ongoing research in the Goldberg lab.

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.

Department Specific Functions

• Support multiple liver disease research studies by performing a variety of duties.
• Maintains study files according to protocol requirements, UM and department policy.
• Recruit and screen participants, obtain informed consent, and follow participants according to study calendar.
• Assist with the startup of new studies within the Goldberg lab.
• Assists in onboarding and training of new study team members.
• Oversee junior research coordinators.
• Performs QA on study binders in preparation of study monitor visits.
• Ensure study medication is kept secure and under the appropriate temperature condition and maintain accurate study drug accountability.
• Ability to work independently and/or in a collaborative environment.
• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
• Prepares IRB submissions including continuing reporting, reportable events, amendments and follow ups to IRB.
• Help process patient specimens (e.g