Clinical Research Project Manager-PRISMS

12-Apr-2024

Neurology - Clinical Research

87792BR

University Job Title

Manager 2, Research Res Support

Bargaining Unit

None - Not included in the union (Yale Union Group)

If Fixed Duration, Period

5 years from date of hire

If Fixed Duration, is continuation possible?

Yes

Other Fixed Duration Date

30-Apr-2029

Compensation Grade

Administration & Operations

Compensation Grade Profile

Manager; Program Leader (24)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Clinical, Research Res Support, Research/Support

Total # of hours to be worked:

37.5

Work Week

Standard (M-F equal number of hours per day)

Work Location

Medical School Campus

Worksite Address

2 Church Street South Doctor's Building
New Haven, CT 06519

Position Focus:

The Department of Neurology is seeking a dynamic Clinical Research Project Manager to lead upcoming PRISMS trial. The Clinical Research Project Manager will report directly to the Associate Director Clinical Research. This position will lead the clinical research project in achieving its research mission, and strategic initiatives, by serving as a direct link between the clinical research team staff, department administration and outside collaborators in all matters concerning this clinical research project. The Clinical Research Project Manager will provide overall project management of a high-profile, multicenter, multi-year clinical trial to assess the ability of an immunological intervention to prevent the emergence of symptoms of Parkinson’s disease in persons with the prodromal syndrome called REM Sleep Behavior Disorder (RBD). In addition, the successful candidate will be a member of a team responsible for day-to-day operations of the clinical research program in the Division of Movement Disorders, Department of Neurology. Responsibilities will include, but not be limited to: being the primary Yale contact and oversight person for the Clinical Trials Center group at the University of Rochester that will be charged with operationalizing the study, overall budgetary management of the study, oversight of vendor management activities with vendors performing imaging and bioanalysis services, oversight of 10-15 clinical sites in conjunction with the Contract Research Organization or Academic Research Organization operationalizing the study and, locally at Yale supervision of 1-2 post-graduate level research trainees and 1 research coordinators, ensuring competent and standardized clinical research practices, along with thorough compliance of standard practices, implementation of Good Clinical Practice (GCP) and training of all staff and faculty working on the clinical research projects. The Clinical Research Project Manager will be an advocate for high quality research, patient service excellence and overall research compliance.

Principal Responsibilities:

Oversees day-to-day clinical operations of the PRISMS multicenter trial in collaboration with the CRO or ARO operationalizing the study.

Ensures policies and procedures are being followed and met on a day-to-day basis in accordance with established department guidelines.

Advises faculty and administrators seeking external funding for research and other sponsored programs on format, regulatory compliance, submission policies, pre and post award requirements and University, School, Federal and State regulations governing sponsored research.

Provides assistance to the principal investigator and department staff in the development of proposals, budgeting, interpretation of sponsor terms and policies and University policies and procedures.

Ensure key personnel are compliant with Conflict of Interest, Human Subject, Animal, Safety, HIPPA and other training mandates.

Keep abreast of laws, regulations, external and internal policies, and procedures governing the administration of grants and contracts and serve as a resource to faculty and staff.

Obtain, evaluate and communicate information on sponsor electronic research processes and procedures.

Coordinate filing of required reports (financial, technical, and patent) in conjunction with other University departments and the CRO or ARO operationalizing the study.

May perform other duties as assigned.

Essential Duties

1. Ensures policies and procedures are being followed and met on a day-to-day basis in accordance with established department guidelines. 2. Advises faculty and administrators seeking external funding for research and other sponsored programs on format, regulatory compliance, submission policies, pre and post award requirements and University, School, Federal and State regulations governing sponsored research. 3. Provides assistance to investigators and department staff in the development of proposals, budgeting, interpretation of sponsor terms and policies and University policies and procedures. 4. Reviews, authorizes, and transmits grant and contract proposals to sponsors; consults with appropriate managerial staff on any exceptions to University policy. 5. Review terms and conditions on award documents; negotiate terms as necessary for interdisciplinary, complex and non-standard proposals and agreements, including subcontracts, clinical trials and state agreements to ensure conformity with University policies. 6. Ensure key personnel are compliant with Conflict of Interest, Human Subject, Animal, Safety, HIPPA and other training mandates. 7. Keep abreast of laws, regulations, external and internal policies and procedures governing the administration of grants and contracts and serve as a resource to faculty and staff. 8. Obtain, evaluate and communicate information on sponsor electronic research processes and procedures. 9. Coordinate filing of sponsor required reports (financial, technical and patent) in conjunction with other University departments. 10. May perform other duties as assigned.

Required Education and Experience

Minimum requirement of Bachelor’s Degree in related field and three years of related experience or an equivalent combination of education and experience.

Required Skill/Ability 1:

Knowledge of the drug development process, prevention, detection, treatment, and clinical trial designs. Knowledge of federal regulations and guidance documents governing the conduct of clinical trials.

Required Skill/Ability 2:

Proven ability to manage and evaluate orientation, education, and professional developmental needs for research staff using the CFR, GCP, ICH, protocol requirements, and research professional resources with the objective of developing and maintaining high functioning of clinical research experts.

Required Skill/Ability 3:

Ability to conduct periodic reviews of the clinical trial portfolio and evaluate the research infrastructure to ensure best use of resources and clinical trial accrual. Proven experience auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance.

Required Skill/Ability 4:

Demonstrated clinical research skills and specialized knowledge of the unique needs of patients undergoing treatment in high acuity trials.

Required Skill/Ability 5:

Ability to assess, prioritize and delegate critical research tasks to support team.

Preferred Education, Experience and Skills:

Bachelor’s Degree and 5 years of clinical research experience with a minimum of 3 years in a management role supervising clinical research in a hospital/academic or industry setting. Degree in a medically related field (nursing, psychology, behavioral , biomedical sciences etc.) preferred.  Advanced degree or certification is a plus.

Preferred Licenses or Certifications:

Certified Clinical Research Professional (CCRP), RN or other similar certification.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

COVID-19 Vaccine Requirement

The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.

EEO Statement:

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

Note

Yale University is a tobacco-free campus