CORE JOB FUNCTIONS

• Coordinates the implementation of multiple complex clinical research protocols.

• Develops SOPs and templates with guidance from the PI/Clinical Research Manager.

• Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.

• Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.

• Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions.

• Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.

• Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.

• Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.

• Organizes/manages site visits and internal/external auditing activities as assigned.

• Coordinates research team meetings; assures communications across-the-board.

• Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.

• Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.

• 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

• Provides daily operational oversight for the clinical research team, ensuring effective coordination of study activities, adherence to best practices, and consistent application of SOPs across trials.

• Acts as a senior mentor and leader to junior research staff, guiding protocol execution, troubleshooting complex operational challenges, and escalating issues when appropriate.

• Coordinates and leads research team meetings, fostering clear, consistent communication across investigators, coordinators, regulatory staff, and ancillary departments.

• Designs and maintain standardized documentation tools to ensure consistent study conduct across the PCCSM research portfolio.

• Oversees eligibility screening, recruitment, and enrollment strategies; develops and implements targeted methods to optimize participant accrual and retention.

• Ensures synchronization of study visits, clinical procedures, diagnostics, and data collection according to protocol‑specified timepoints.

• Leads safety oversight activities, including monitoring, documentation, reporting, and follow‑up of unanticipated problems, adverse events, and protocol deviations.

• Maintains and strengthens global partnerships with industry sponsors, CROs, and academic collaborators, serving as a trusted operational lead and liaison for PCCSM‑led trials.

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

• Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months

• Minimum 4 years of relevant experience

Knowledge, Skills and Attitudes:

• Skill in collecting, organizing and analyzing data.

• Ability to recognize, analyze, and solve a variety of problems.

• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.

• Ability to process and handle confidential information with discretion.

• Ability to work independently and/or in a collaborative environment.