GENERAL PURPOSE:

The Clinical Research Manager (CRM) is responsible for the day to day oversight and management of Clinical Trials Office clinical research staff assigned to the specific Disease Working Group (DWG) of responsibility. The CRM will manage the daily operations within the organization's DWGs and monitors research activity to ensure compliance with Standard Operating Procedures and Good Clinical Practices.

JOB DUTIES AND RESPONSIBILITIES:

Oversight of assigned study personnel including orientation, training, documentation of core competencies, certification mandates, safety/responsible conduct of research education and performance evaluations, including the following tasks:

• Manages the day to day operations, issue resolution, and supervision of assigned staff.

• Assigns staff to protocols prior to PRMC submission.

• Completes annual performance evaluations.

• Performs QA and supervision of team OnCore entries, research tabs and reports.

• Reviews applications, interviews and hires staff as needed.

• Addresses discipline issues.

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

• Develops and implements strategies to promote adherence to cultural competency guidelines, meets participants' needs for language translation, health literacy, etc.

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

Manages the studies and pipeline portfolio of assigned DWG, including the following tasks:

• Operational assessment of proposed new research protocols.

• Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators' academic administrative personnel, other departments.

• Provides point of contact for DWG physicians.

• Provides coverage and back-up for team CRCs as needed.

• Provides leadership in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected time-lines.

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

• Performs safety and quality improvement efforts, minimizing risk/safety threats.

• Prepares for and responds to internal and external audits.

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

Professional Development:

• Obtains and/or maintains clinical research certification.

• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.

• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.

• Maintains CITI and Conflict of Interest (COI) certification and renewal as required.

• Maintains proficiency in UR-specific research software needed to manage clinical research protocols.

• Assumes personal responsibility for keeping up with new developments in the field, related literature, and relevant clinical standards.

• Assists in helping others in same. Participates in protocol-related training as required.

Participates in department specific goals including (but not limited to the following):

• Identifies and develops new department specific SOPs.

• Updates and revises current SOPs as needed.

• Participates in staff recruitment and retention initiatives.

• Participates in department wide team building and training activities.

Complies with Good Clinical Practice and the Code of Federal Regulations:

• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines.

• Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.

Other duties as assigned

QUALIFICATIONS:

• Bachelor's Degree required or equivalent combination of education and experience required.

• Master's Degree in a health related field preferred.

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

• 1 year leadership experience preferred.

• Fluent English language skills (oral and written) required.

Preferred:

• 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,

• Fully adheres to applicable safety and/or infection control standards.

• 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 for patients).

• 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 required.

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: $70,197 - $105,295 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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Full/Part Time: Full-Time
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