Senior Clinical Research Associate
Reporting to the Assistant Director of Quality Assurance (QA) and Monitoring for YCCI, the incumbent conducts clinical research monitoring for clinical trials conducted at the Yale School of Medicine and external (non-Yale) sites.
Working collaboratively with key stakeholders across the Yale School of Medicine, this role advocates for the advancement of critical strategic objectives that promote effective, efficient, and compliant management of clinical studies. The Senior Clinical Research Associate will be responsible for independently tracking, planning, ensuring the research activities are conducted in accordance with approved protocols and reporting monitoring activities. The Senior Clinical Research Associate will be responsible for developing project specific monitoring plans via evaluation of the project risk and in accordance with FDA guidance, as well as monitoring for multiple clinical trials. The monitoring activities performed include but are not limited to: Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, Close Out Visits per protocol specific monitoring plans. The Senior Clinical Research Associate may be responsible for management and oversight of protocol specific Data and Safety Monitoring Boards.
The mission of the Office of QA & Monitoring within YCCI is to foster a supportive environment conducive to achieving Yale’s clinical research mission and provide a central resource to aid investigators, research groups and leadership with respect to trial development, execution, and oversight.
Frequent travel, beyond CT, is required.
This position will be partially funded by the sponsored awards it supports.
- Oversees the advancement and growth of the program. Gives direction and leadership supporting the philosophy, mission, strategy, and annual goals and objectives. Assumes primary accountability for disseminating and publishing all program information to create public awareness and support of the program.
- Plays a key role in strategic planning. Works closely with leadership, internal and external colleagues and community residents to develop new initiatives to support the strategic direction of the organization and implements long-term goals and objectives to achieve the successful outcome of the program.
- Develops an annual budget and operating plan to support the program. Ensures program operates within approved budget. Monitors and approves all budgeted program expenditures. Manages all program and project funds according to established accounting policies and procedures.
- Builds and maintains a program evaluation framework to assess the strengths of the program and to identify areas for improvement. Monitors the program activities on a regular basis and conducts an annual evaluation according to the program evaluation framework. Identifies and evaluates the risks associated with program activities and takes appropriate action to control the risks. Reports evaluation findings to appropriate stakeholders and recommends changes to enhance the program, as appropriate
- Ensures that program activities operate within the policies and procedures of the organization and activities comply with all relevant legislation/regulatory requirements.
- Identifies, solicits, and cultivates community partnerships and collaborations to assist in the development and growth of the program. Develops the metrics to identify and measure the success of the program. Responsible for measurements of grant success and related evaluation.
- Identifies and evaluates potential future funding sources, and contributes to the submission of grants and contracts supporting the program, including the annual submission and writing of all content areas and budgetary sections of grant applications.
- Develops the administrative infrastructure of the program. Manages human resource and administrative functions of the program, including staffing and hiring, supervision, performance development, counseling and discipline, if warranted. Oversees and manages information systems, facilities, and space needs.
- Investigates, identifies, implements, and oversees the maintenance of systems to gather, track, and report information to support the initiatives of the program. Tracks all program activities and regularly informs leadership of progress on each initiative. Recommends structural or programmatic adjustments, changes or additions based on full knowledge of missions, goals, and objectives.
- Initiates, designs, and manages the compilation of program communications; identifying outreach potential, and promoting philanthropic and collaborative support of the program. Contributes to the development and assists in the management of content on the program’s website and monitors all changes and additions to the editorial content.
- Performs other duties as assigned.
Required Education and Experience
Bachelor’s degree in a related field. Six years of related experience or an equivalent combination of education and experience.
Required Skill/Ability 1:
Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.
Required Skill/Ability 2:
Demonstrable understanding of clinical research processes and procedures from study start-up to study close out with an experience as a clinical research auditor, clinical research associate or equivalent. Extensive knowledge and application of auditing or monitoring techniques and practices.
Required Skill/Ability 3:
Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information.
Required Skill/Ability 4:
Organized with the capability of handling multiple/diverse projects simultaneously. Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule.
Required Skill/Ability 5:
Superior interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.
Preferred Education, Experience and Skills:
Master’s Degree in related field. Experience in auditing or monitoring of clinical trials.
Preferred Licenses or Certifications:
SOCRA/ACRP (or equivalent) certification.
Weekend Hours Required?
Evening Hours Required?
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. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
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.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: firstname.lastname@example.org.
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