Sr Clinical Research Spec
The Clinical Research Coordinator III (CRC III) is an experienced Clinical Research Professional responsible for providing leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. Under the ultimate responsibility of the Principal Investigator (PI) and/or Clinical Research Manager, the CRC III will manage multiple studies day-to-day operations, carry out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, ensure each study's integrity, and mentor less experienced research staff. 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 administrative and human resources tasks; and facilitate across-the-board flow of information, orchestrating study activities and personnel.
JOB DUTIES AND RESPONSIBILITIES:
Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual and may perform second eligibility checks as delegated by Supervisor.
Addresses e-mail and phone inquiries, participates in discussions with candidates in clinic, and consents for treatment and non-treatment trials.
Plans study timelines and schedules appointments and study visits.
Manages and organizes case report forms, source documents and research records.
Accurately enters research data into data collection forms and/or study databases
Assists in conducting quality checks for data accuracy with data source records as assigned.
Develops and implements strategies to promote adherence to cultural competency guidelines, meets participants’ needs for language translation, health literacy, etc.
Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
Independently manages and coordinates multiple complex studies and study patients. Maintains study continuity, coordinates study participants and research procedures including the following tasks:
Identifies and documents adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
Provides leadership in problem solving logistical challenges to ensure study objectives are achieved according to protocol and projected time-line.
Performs data collection and data entry activities according to protocol requirements and established operational procedures and timelines.
Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences, protocol deviations; develops and implements preventive/corrective actions.
Assists in identifying and developing data collection tools.
Performs quality checks for data accuracy, reports/follows-up with discrepancies.
Assists in safety and quality improvement efforts, minimizing risk/safety threats.
Prepares for and responds to internal and external audits.
Effectively communicates with the research team, sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, other departments.
Maintains all logs, Research Tabs and OnCore
- Maintains all logs, including OnCore entry and research tabs in the EMR, according to UR and department SOPs.
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.
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.
Other duties as assigned.
3 years clinical research or relevant work experience
Or equivalent combination of education and experience
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.
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: $59,197 - $82,888 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.
Apply for Job
Location: School of Medicine & Dentistry
Full/Part Time: Full-Time