YCCI Senior Clinical Research Associate

Overview

Reporting to the Assistant Director of Quality Assurance (QA) and Monitoring for the Yale Center for Clinical Investigation (YCCI), the YCCI Senior Clinical Research Associate conducts clinical research monitoring for clinical trials performed at the Yale School of Medicine and external (non-Yale) sites.

Works directly and in collaboration with YCCI leadership, departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review the activities associated with human subjects research in terms of safety, compliance, and integrity of clinical trials conducted at Yale and at collaborating institutions. Performs site qualification visits to determine the feasibility and appropriateness of a potential site before site selection. 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. Monitors clinical trial data and regulatory documents per the protocol specific monitoring plan on-site and remotely to ensure research integrity and compliance with the IRB approved protocol, institutional policies, state and federal regulations, and ICH Good Clinical Practice. Reviews medical records of study participants, determines the impact of non-compliance (e.g. violations of federal regulations, GCP and University policies) on study plans/processes, makes judgments and communicates findings to investigators. Identifies research non-compliance and ensures reporting to appropriate leadership within YCCI, Departmental leadership, HRPP and the IRB. Exercises judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities. Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance. Assesses the risk and stratifies the study from a QA/regulatory compliance perspective based on clinical research experience and regulatory knowledge. Reviews findings from monitoring visits with investigators and research staff and advises and monitors appropriate action plans. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure compliance. Works directly with Sponsor-Investigators on the development, implementation and oversight of protocol-specific data and safety monitoring boards. May perform other duties as assigned.

The mission of the Office of Quality Assurance & 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 Connecticut, is required.

This position will be partially funded by the sponsored awards it supports.

Required Skills and Abilities

1. Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes.
2. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.
3. Extensive knowledge and application of auditing or monitoring techniques and practices.

Preferred Skills and Abilities

1. Master's degree or advanced degree in a related field (e.g., public health, public administration, business administration).
2. SOCRA/ACRP (or equivalent) certification
3. At least 3 years of experience as an auditor, clinical research associate or equivalent.
4. Experience in administrative support of research oversight committees such as Scientific Review, Data and Safety Monitoring Boards, Institutional Review Boards, etc.

Principal Responsibilities

1. 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.
2. 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.
3. 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.
4. 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
5. Ensures that program activities operate within the policies and procedures of the organization and activities comply with all relevant legislation/regulatory requirements.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.