Research Quality Analyst - 40 hours, Day shift

Location: Burlington, MA
Job ID: 175877-1A
Date Posted: Jun 17, 2022
Category: Professional

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Job Description

Welcome To

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.

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.  Performs various ongoing monitoring activities including but not limited to reviewing and evaluating monitoring follow-up reports, regulatory binder maintenance according to Research Policies and SOPs, GCP and federal regulations; general oversight of ClinicalTrials.gov records; and disbarment or misconduct reviews. Reviews completed consent forms and patient medical records to ensure consent was obtained properly and patients are linked to their study account.  Compiles reports based on findings. 

8.  Tracks required research training completion and advise research staff on training requirements.

9. 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.

10. Evaluates current operational practices and recommends process improvements to ensure continued compliance with regulatory requirements and institution expectations.

11. Evaluates new protocols for complexity and risk assessment, highlight endpoints, create reports and communicate concerns with the study team and Research Quality Program Manager, prior to study implementation. Collaborates with study staff to ensure study enrollment readiness. Maintains database of completed assessments.

12. Compiles data and creates reports for Research Administration.

13. Authors and revises Research Administration and IRB SOPs.

14. Participates in or leads training sessions.

15. Keeps up to date with current research regulations and institution SOPs.

Minimum Qualifications:

Education: Bachelor degree.

Licensure, Certification & Registration: SoCRA or ACRP certification is desired but not required.

Experience: Minimum of 3 years in a research setting.  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.

Shift

40 hours, Day shift

About Us

Beth Israel Lahey Health is dedicated to improving health and wellness and making a difference in the lives of our patients, their families and all members of the communities we serve.  Formed in March 2019, Beth Israel Lahey Health is a patient-centered, integrated care delivery system providing a continuum of services spanning academic, tertiary and community hospitals, dedicated orthopedic and psychiatric hospitals, primary and specialty care, community acute care, ambulatory care, behavioral services and home health.  Beth Israel Lahey Health Performance Network is a unified joint contracting and population health management organization, jointly governed by participating physicians and hospitals.

Equal Opportunity Employer/Minorities/Females/Disabled/Veterans.