Location: Burlington, MA
Job ID: 161524-1A
Date Posted: May 4, 2021
Welcome to Lahey Hospital & Medical Center, part of Beth Israel Lahey Health. Lahey Hospital & Medical Center is a world-renowned tertiary medical center known for its innovative technology, pioneering medical treatment and leading-edge research. A teaching hospital of Tufts University School of Medicine, the hospital provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation. It is a national leader in a number of health care areas, including stroke, weight management and lung screenings, among many others. Lahey also helps to advance medicine through research and the education of tomorrow's health care leaders.
About the Job
Under the direction of the Manager, Research Quality Program and/or Director, Research Administration the Research Quality Analyst provides general quality oversight to clinical trials conducted at Lahey Hospital & Medical Center and its affiliated sites and identifies and addresses quality and compliance issues. The Analyst performs data management and analysis in accordance with Lahey Hospital & Medical Center SOPs, Federal (FDA, OHRP) and State regulations relating to clinical research. The Analyst audits clinical trial and research regulatory records, assures corrective actions are implemented, evaluates clinical trial protocols for complexity, provides support and training to all Lahey colleagues engaged in clinical research activities, and authors or revises institution SOPs. The ideal candidate has research coordination experience, and monitoring or auditing experience is a plus
Essential Duties & Responsibilities including but not limited to:
1. Monitors compliance with Federal (FDA, OHRP), State and institution regulations and SOPs relating to clinical research.
2. Provides general quality oversight to clinical trials conducted at Lahey Hospital & Medical Center and its affiliated sites and identifies and addresses quality and compliance issues as they arise.
3. Supports investigators and study support staff to ensure that trials are conducted in accordance with sponsor protocols, Good Clinical Practice (GCP) and institution SOPs.
4. Participates in or leads random, routine, focused and for-cause audits for protocol-related and regulatory-related compliance.
5. Assists investigators and study staff in preparing for an external (e.g. FDA or sponsor) audit.
6. Drives research quality improvements by evaluating audit results and reported deviations with investigators, study staff, Research Administration, Institutional Review Board (IRB), clinical departments and/or sponsors to determine root causes of deviations and deficiencies and to oversee corrective actions.
7. Evaluates and makes corrective action decisions concerning Protocol Deviations that are reported to Research Administration and the IRB. Escalates critical deviations to Research Quality Manager, IRB Chair or the Research Compliance Committee as needed.
8. Evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements and institution expectations.
9. Evaluates new protocols for complexity using an internal scoring tool (ReCET). Collaborates with study staff to determine final protocol complexity and workload scores. Maintains database of complexity scores, creates reports and communicates complexity and workload data to study staff and the Director of Research Administration.
10. Compiles data and creates reports for Research Administration.
11. Authors and revises Research Administration and IRB SOPs.
12. Participates in or leads training sessions.
13. Keeps up to date with current research regulations and institution SOPs.
Maintain strict adherence to the Lahey Hospital and Medical Center Confidentiality policy.
Incorporate Lahey Hospital and Medical Center Standards of Behavior and Guiding Principles into daily activities
Comply with all Lahey Hospital and Medical Center Policies.
Comply with behavioral expectations of the department and Lahey Hospital and Medical Center.
Maintain courteous and effective interactions with colleagues and patients.
Demonstrate an understanding of the job description, performance expectations, and competency assessment.
Demonstrate a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
Participate in departmental and/or interdepartmental quality improvement activities.
Participate in and successfully completes Mandatory Education.
Perform all other duties as needed or directed to meet the needs of the department.
Education: Bachelor degree.
Licensure, Certification & Registration: Required
Experience: Experience coordinating clinical trials.
Skills, Knowledge & Abilities:
Knowledge and understanding of GCP and institution SOPs required.
Excellent oral and written communication skills required.
Strong user knowledge of Microsoft Word, PowerPoint and Excel; Leadership ability and excellent interpersonal skills.
Ability to work under minimal direction, independently or as part of a team if necessary.
Key Words: Research, Clinical Trials, Quality, Compliance, SOP's, FDA, OHRP, Clinical Research, Good Clinical Practice (GCP), Audit, Protocols, ReCET, Burlington, MA
40 Hour / Day
Beth Israel Lahey Health is an integrated system providing patients with better care wherever they are. Care informed by world-class research and education. We are doctors and nurses, technicians and social workers, innovators and educators, and so many others. All with a shared vision for what healthcare can and should be. We are committed to attracting, developing and retaining top talent. We strive to create a diverse and inclusive workplace that reflects the communities in which we work and serve. With a team approach to care, we encourage learning and growth at all levels and offer competitive salaries and benefits.
Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.