Clinical Research Coordinator 2

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                                                              

• Bachelor’s degree in relevant field required

• Minimum 2 years of relevant experience

Department Specific Functions

• Serves as coordinator for the Program Management Toolkit (PMT) 

• Assists on the development and implementation of the Retention Team Training Plan

• Provides training to all new retention team members 

• Trains all program staff in the utilization of Program Management Toolkit (PMT)

• Oversee retention in-person appointments and assist with the quality assurance of retention activities

• Oversees all project incentives/material are being distributed accordingly and will request materials when needed 

• Assists in the development and implementation of Pilot Projects 

• Assists with the implementation and monitoring of the Share Ride Pilot Project (RSPP) 

• Responsible for the expansion and monitoring of the Computer Assisted Telephone Interviewing (CATI) program.  

• Gather staff performance data (phone calls, SMS, email, in-person) and develops plans with manager to enhance performance quality when needed 

• Provides retention related activities to participants including phone calls, SMS, emails, and in-person visits 

• Conducts outreach activities

• Collects and reports program data

• Monitors that retention activities are provided according to the study protocol.

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