Lahey Health Clinical Research Auditor, 40hrs in Burlington, Massachusetts

Responsibilities Under the direction of the Research Quality Assurance Program Manager the Clinical Research Auditor will conduct audits and reviews of clinical trials conducted at Lahey Hospital & Medical Center and its affiliated sites to help ensure research participant safety, acquisition of high quality data and compliance with federal and state regulations and institutional policies. Additional responsibilities encompass providing support in various Quality Assurance Program functions.

Essential Duties & Responsibilities including but not limited to:

  1. Lead random, routine, focused and/or for cause audits to assess the effectiveness of quality management, compliance to approved clinical study protocols and regulatory related compliance.

  2. Prepare for scheduled audit by thoroughly reading and understanding selected protocol requirements, federal regulations, Good Clinical Practice guidelines and Lahey policies

  3. Analyze audit findings to appropriately assign major or minor violations, rating the audit and drafting a Final Audit Report for review and approval by the Research Quality Program Manager.

  4. Summarize and present audit findings to the Principal Investigator (PI), Site PIs, and study staff at the end of on-site auditing activities during an exit interview.

  5. Ensure timely issuance of audit reports, audit observation forms, oversee audit response process and drive audits to closure

  6. Maintain and enhance procedures for communicating audit observations and tracking audit responses.

  7. Develop and maintain a high level of understanding of Lahey?s processes and quality systems, and demonstrates a high level of professionalism, judgment and overall competence in an audit setting.

  8. Assists investigators and study staff in preparing for an external (e.g. FDA or sponsor) audit.

  9. Assists the IRB in preparing for an external (e.g. FDA or sponsor) IRB audit and provides support during the inspection.

  10. Contributes to research quality improvements by evaluating audit results 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.

  11. Identify compliance risk areas and assists with the development and implementation of policies and corrective action plans where indicated.

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

  13. Monitors compliance with federal (FDA, OHRP), state and institution regulations and SOPs relating to clinical research.

  14. Provide support to other assignments as directed by the Research Quality Assurance Program Manager

  15. Performs other duties as assigned by the Research Quality Assurance Program Manager Qualifications Education: Bachelor degree preferred.

Licensure, Certification & Registration: Required

Experience: Experience coordinating clinical trials. Experience with cooperative group studies required. Auditing experience preferred.

Skills, Knowledge & Abilities: Knowledge and understanding of GCP, federal and local regulations, and institution SOPs required.

Excellent oral and written communication skills required.

Strong user knowledge of Microsoft Word

Ability to manage interpersonal relationships and interact/communicate with clarity, tact and courtesy with internal and external personnel.

Ability to manage time, multi-task and problem solve.

High level of attention to detail and accuracy.

Excellent organizational and prioritization skills.

Ability to work under minimal direction, independently or as part of a team if necessary.

Ability to travel (25-75%) of time Shift DAYS

About Lahey Health

At Lahey Hospital & Medical Center, as one of the world's premier health care organizations, we provide superior health care leading to the best possible outcome for every patient. We exceed our patients' high expectations for service each day. We also help advance medicine through research and the education of tomorrow's health care leaders

We care for our patients with compassion and openness, unsurpassed expertise, a drive for continuous learning improvement, and with respect, caring, teamwork, excellence and commitment to doing our personal best.

Join our team and our mission of excellence by applying today!

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Lahey Health

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Lahey Health is committed to equal opportunity. We recruit, hire, train and promote without discrimination due to race, color, religion, gender, sexual orientation, national origin, ancestry, marital status, age, disability, citizenship, veteran status, or any other protected job status. Lahey Clinic provides equal employment opportunities to minorities, females, veterans, and disabled individuals, as well as other protected groups. Please click here to view the "EEO is the Law" poster.