Clin Research Coord Lead

Rochester, NY


The Clinical Research Project Manager Lead (CRPM Lead) is an experienced Clinical Research Professional, ’manager- track’ position, responsible for providing leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. The position provides mentorship and training to team members and provides coverage for Sr. Clinical Research Project Managers. Under oversight of URCC Sr. Leadership, Principal Investigators (PIs), and/or Sr. Clinical Research Project Manager, the CRPM Lead will manage multiple studies’ day-to-day operations, carry out project management for large, national clinical trials run through the URCC NCORP network from protocol development and initiation to study close-out according to regulatory/NCI guidelines, ensure each study’s integrity, and mentor less experienced CRPMs. S/he will monitor and maximize adherence to research standards, regulatory guidelines, and approved operational procedures; work closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to study protocol; manage study-related tasks; and facilitate across-the-board flow of information, orchestrating study activities and personnel. The CRPM Lead will facilitate excellent customer service andguidance to clinical and study teams in the clinical trials environment. The CRPM will leverage their advanced experience to be assigned to more complex, demanding projects and will regularly work with new CRPMs to train and onboard them.


Assumes leadership assignments:

  • Serves as back-up to the Sr. Clinical Research Project Manager and assists or covers CRPM duties and responsibilities as assigned.

  • Takes a leadership role in special projects as assigned by URCC leadership and/or the Sr. CRPM.

  • Problem solves complicated issues relating to research processes and core support; assists in the education and training of such information with applicable URCC staff.

  • Serve as site auditor, primarily reviewing selected patient cases to ensure

  • compliance with protocol; assist Lead Auditor in compiling information gathered during the audit for the final report to the NCI

Coordinate multiple high volume, multisite clinical research projects:

  • Serve as the primary contact for protocol and data-related questions and issues from off-site locations (typically 20-100) nationally

  • Ensure off-site investigators and their clinical research staff understand and adhere to all aspects of assigned protocols, procedures, interventions, and

  • standards for documentation and communication

  • Train site research staff on details of study activities, including inclusion and exclusion criteria, informed consent procedures, process for source documentation and case report form (CRF) completion, and adverse event reporting

  • Monitor studies regularly for conformity with standard operating procedures, and verify data to ensure compliance with requirements of the protocol, Research Base, IRB, University and federal regulations

  • Track study-specific metrics (i.e., overdue data, open queries, etc.) and ensures issues are addressed promptly.

  • Learn and maintain working knowledge of software and/or specialized equipment, procedures and interventions used in each project

  • Develop and maintain workflow, records of research activities, and prepare periodic and ad hoc reports, as required by investigators and/or regulatory bodies.

  • Ensure proper reporting of adverse events to PI and Research Base Administration

  • Maintain database integrity; review and evaluate patient data for statistical analysis, work with biostatistics team to resolve discrepancies or problems

  • Develop and produce reports of study data for project staff and stakeholders, including study deviations and adverse events. Contributes meaningful information to enhance publications or grant applications

  • Attend and present updates at weekly study management team meetings

Study agents, supplies and equipment:

  • Assist Investigational Drug Service in distribution of study agent to off-site locations

  • Design and build biospecimen collection kits

  • Receive requests for and ship study-specific drug, supplies and equipment (e.g., devices such as activity trackers, heart rate monitors TENS units, recording equipment, training materials, manuals) for active clinical trials

  • Maintain shipping logs and database, track expiring supplies and communicate with sites, replace with in-date supplies

  • Retrieve, log and store biospecimens received from off-site locations Produce laboratory reports

Assists in training less experienced research personnel in research competencies, UR and department SOPs and protocol specific training.

Assumes the trainer role for proficiency in use of UR-specific research software needed for their clinical research studies.

Study development

  • Assist Principal Investigator and study team in the development of protocols, data collection forms, training materials

  • Create patient instructions and calendars

  • Develop data tracking forms for new clinical trials

  • Determine supply requirements for new projects and order supplies

  • Review and edit protocols and data forms for new projects under development

Other duties as assigned



  • Bachelor’s Degree or equivalent combination of education and experience

  • 4 years clinical research or relevant work experience or equivalent combination of education and experience

  • Fluent English language skills (oral and written).

  • Ability to effectively manage complex research protocols/procedures.

  • Proficiency in medical terminology, the clinical research process and applicable regulatory guidelines, standards.

  • Proficiency in managing multiple and competing priorities/demands.

  • Thorough knowledge of and established track record in assuring GCP, Responsible Conduct of Research standards, applicable safety standards, OSHA guidelines, throughout study implementation.

  • Exceptional interpersonal, organizational, and time management skills; highly collaborative, promotes teamwork.

  • Ability to build collaboration among research team members, laboratory staff, patients and families, clinical services (requires tact, sensitivity, clarity, flexibility, empathy)

  • Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet.

  • Possesses a high degree of self-motivation; recognized ability to function independently.


  • Clinical Research Certification by the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA)

  • Project Management Certification

The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations.

How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

Pay Range

Pay Range: $ 62,200 - $ 93,300 Annually

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

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