Full-Time
Clinical Research Manager
University of Rochester
Private research university in Rochester, NY
Compensation Overview
$70.6k - $105.8k/yr
Rochester, NY, USA
In Person
Bachelor's, Master's
Category
 Biology & Biotech (1) |
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Required Skills
Microsoft Office
Medical Terminology
Word/Pages/Docs
Quality Assurance (QA)
Excel/Numbers/Sheets
PowerPoint/Keynote/Slides
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Requirements
- A bachelor's degree and four years of relevant experience are required, or an equivalent combination of education and experience.
- Certified Clinical Research Professional certification is required within one year.
- Society of Clinical Research Associates certification in clinical research is required within one year.
Responsibilities
- Oversee the day-to-day management of the assigned Clinical Trials Office and assigned staff.
- Manage daily Clinical Trials Office operations and monitor research activity for compliance with Standard Operating Procedures and Good Clinical Practices.
- Oversee assigned study personnel, including orientation, training, core competency documentation, certification mandates, safety and responsible conduct of research education, and performance evaluations.
- Manage day-to-day operations, resolve issues, and supervise assigned staff.
- Assign staff to protocols before Protocol Review and Monitoring Committee submission.
- Complete annual performance evaluations.
- Perform quality assurance and supervise team OnCore entries, research tabs, and reports.
- Review applications, interview candidates, and hire staff as needed.
- Address discipline issues.
- Oversee and facilitate eligibility screening and study recruitment activities.
- Implement strategies to increase accrual and perform second eligibility checks.
- Develop and implement strategies to promote adherence to cultural competency guidelines and meet participants' needs for language translation and health literacy.
- Train staff in the use of University of Rochester-specific research software needed for clinical research studies.
- Manage the studies and pipeline portfolio of the assigned disease working group.
- Complete operational assessments of proposed new research protocols.
- Communicate with the research team, sponsors, data coordinating centers, compliance monitors, collaborators, investigators, academic administrative personnel, and other departments.
- Serve as the point of contact for disease working group physicians.
- Provide coverage and backup for team members as needed.
- Lead the resolution of logistical challenges so study objectives are achieved according to protocol and projected timelines.
- Lead protocol implementation and study progress and keep investigators apprised of study progress.
- Perform safety and quality improvement efforts to minimize risks and safety threats.
- Prepare for and respond to internal and external audits.
- Plan and operationalize strategies to monitor, document, report, and follow up on unanticipated occurrences and protocol deviations.
- Develop and implement preventive and corrective actions.
- Obtain and maintain clinical research certification.
- Maintain required skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
- Maintain Collaborative Institutional Training Initiative and Conflict of Interest certification and renewal as required.
- Maintain proficiency in University of Rochester-specific research software needed to manage clinical research protocols.
- Keep current with developments in the field, related literature, and relevant clinical standards.
- Assist colleagues in keeping current with developments and standards.
- Participate in protocol-related training as required.
- Participate in department-specific goals.
- Identify and develop new department-specific Standard Operating Procedures.
- Update and revise current Standard Operating Procedures as needed.
- Participate in staff recruitment and retention initiatives.
- Participate in department-wide team-building and training activities.
- Comply with Good Clinical Practice and the Code of Federal Regulations.
- Keep current with federal, state, sponsor, and institutional policies and laws, Standard Operating Procedures, and guidelines.
- Keep current with industry standards, best practices, and trends in therapeutic areas relevant to research studies.
- Perform other duties as assigned.
Desired Qualifications
- A master's degree is preferred.
- Previous leadership experience is preferred.
- Demonstrated leadership skills and competency are preferred.
- The ability to effectively manage complex research protocols and procedures is preferred.
- Proficiency in medical terminology, the clinical research process, and applicable regulatory guidelines and standards is preferred.
- Proficiency in managing multiple and competing priorities and demands is preferred.
- Thorough knowledge of and an established track record in assuring Good Clinical Practice, Responsible Conduct of Research standards, applicable safety standards, and Occupational Safety and Health Administration guidelines throughout study implementation are preferred.
- Adherence to applicable safety and infection control standards is preferred.
- Exceptional interpersonal, organizational, and time management skills, with a collaborative approach that promotes teamwork, are preferred.
- The ability to build collaboration among research team members, laboratory staff, patients and families, and clinical services is preferred.
- Proficiency in Microsoft Office, including Word, Excel, and PowerPoint, email, and the internet is preferred.
- A high degree of self-motivation is preferred.
- The recognized ability to function independently is preferred.
The University of Rochester is a research university with programs spanning the humanities, health care, business, education, music, engineering, and the sciences.
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