Senior Clinical Trials Monitor

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Description

The Senior Clinical Trials Monitor develops and initiates a clinical trials monitoring process to support compliance with applicable regulations.

JOB DESCRIPTION:

• Oversees site monitoring of clinical trials and follow up activities.
• Develops guidelines for collection of clinical data and/or administration of clinical trials; develops guidelines for new protocols.
• Trains and orients new clinical trials monitoring staff. Assigns project tasts and evaluates and provides feedback to staff on performance.
• Provides monitoring support for all facets of clinical trials with special emphasis on institutional (investigator-initiated) and Cooperative Group sponsored trials.
• Leads and conducts a variety of monitoring activities intended to facilitate and assure that clinical trials comply with the requirements of the approved study protocol, the approving Institutional Review Board, Emory University and applicable Food and Drug Administration (FDA) and other regulatory requirements. Such activities may include: pre-study resource evaluations, monitoring of ongoing trials, and close-out monitoring of completed trials.
• Conducts monitoring activities in accordance with established procedures.
• Develops and utilizes appropriate monitoring check-lists and report templates to record and report monitoring findings.
• Documents monitoring activities in writing, using appropriate report formats and communicates such findings to the appropriate parties (clinical trials management, the principal investigator, and designated members of the regulatory and clinical trials staff.)
• Reviews the accuracy, completeness and timeliness of completed study related records, case report forms and other documents.
• Compares reported data with original source documents.
• Reviews study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines.
• Reviews drug or device accountability, tracking records, and clinical research pharmacy processes.
• Verifies that appropriate storage, supply, usage, instruction, documentation and disposition are in place and followed.
• Verifies the following items for clinical trials: protocol compliance (i.e. subject recruitment and eligibility criteria and informed consent procedures); that only designated investigator(s) and/or appropriate clinical research staff are performing clinical trial functions; that regulatory compliance is being maintained (i.e. that investigators are providing and maintaining all study related documents as required.)
• Promptly communicates any serious deficiencies noted during monitoring to the appropriate parties.
• Works cooperatively with clinical research staff and investigators to address their concerns and to communicate findings that can lead to improved clinical trial performance and/or compliance.
• Maintains a record of all correspondence, monitoring reports and other written documentation in accordance with operating procedures.
• Participates in meetings and in-service training activities.
• Maintains in strict confidence all confidential information regarding clinical trials and clinical research study sponsors.
• Promotes a work environment that stresses and demonstrates confidential practices.
• Follows Emory University and HIPPA compliance policies.
• Performs related responsibilities as required.

MINIMUM QUALIFICATIONS:

• A bachelor's degree in nursing or a related scientific field; a master's degree is preferred.
• Five years of clinical research experience which includes three years in monitoring or administering complex clinical trials.
• A sound knowledge of ICH and Food and Drug Administration's Good Clinical Practices regulations.
• Attention to detail, organizational skills, interpersonal skills, and effective oral and written communication skills.
• A knowledge of basic computer programs, such as MSWord and Access.

This position is intended for clinical researcher and all clinical training requirements must be tracked through Emory Healthcare under the CLINICAL RESEARCHER for individuals hired in this job classification.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

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Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law. Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination. Emory University complies with Executive Order 11246, as amended, Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity and affirmative action. Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322.

Emory University is committed to providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at 404-727-9877 (V) | 404-712-2049 (TDD). Please note that one week advance notice is preferred.