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Site Monitor

Company: University Of Michigan
Location: Ann Arbor
Posted on: May 3, 2021

Job Description:

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How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

This position will provide clinical site management, regulatory oversight and clinical site monitoring support for multi-site trials coordinated by the Oncology Clinical Trials Support Unit (O-CTSU) from trial start-up through trial closeout. The incumbent will act as a liaison between the clinical sites, coordinating center study staff, the O-CTSU as well as Sponsors/Supporters to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory requirements.

Facilitate and manage discrepancies within study databases (including CTMS and electronic case report forms/data capture systems). Performs source document review/source document verification. Reviews and interpret collected data per applicable regulatory, protocol and institutional guidelines. Application of clinical research regulations, institutional/department standard practice guidelines and study requirements to confirm compliance, data integrity and subject safety. Generate written communication to participating site staff indicating monitoring visit scheduling, findings, and required actions. Create written reports reflecting monitoring activities, findings and actions for filing in the trial master file and sharing with Sponsors and/or Supporters, as required. Participates in project teams to develop and employ methods to manage non-compliance (as applicable). Employees in this classification are required to have a minimum of a Bachelor degree in a recognized field of science or learning which is directly related to the duties of the position.

Maintain working knowledge of study manual of operations for assigned studies, and standard data collection procedures, Monitoring Plan and other study documents. Support maintenance of master trial files and manages the study progress in relation to the project timelines. Provides updates on clinical site enrollment, data collection and compliance with approved protocol version, GCP and ICH guidelines. Prepare clinical sites for study start-up by creation of electronic case report form (eCRF)/data clarification forms (DCF); eCRF training.

Conduct ongoing monitoring visits per study requirements/needs. Travel required approximately 30% of the time. Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the O-CTSU. Supports the maintenance and organization of project documentation and records. Act as a liaison between the clinical site(s) and the O-CTSU to resolve any CTMS and/or eCRF issues/queries/DCFs that may arise throughout the course of the study, as required.

Other responsibilities may include but are not limited to; updating and revision of SPGs, training and orientation of study staff, organization of coordinator/investigator meetings. Participate in group and department initiatives. Perform other duties as assigned by management. This position has the opportunity to function in a fully remote capacity.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Responsibilities*

* Assist study teams with aspects of clinical trial coordination including: conduct Site Selection Visits (as applicable), Site Initiation Visits, Interim Site Visit and Close-out Visits per study, institutional and applicable regulatory/contractual requirements
* Conduct remote and on-site monitoring visits per study requirements
* Coordinates and facilitates accurate timing of monitoring visits (inclusive of preparation/follow-up activities)
* Escalates/Follows up with respective staff for significant and/or unexpected findings
* Collaborates with study staff to ensure effective/efficient sharing of information
* Creates regulated documents for accurate tracking, collection, and recording of review/outcomes.
* Follows through with O-CTSU and clinical site staff questions/concerns/issues
* Expeditiously routes AE and SAE information between staff, PI, and oversight agencies as appropriate
* Possibly attend investigator and scientific meetings
* Serves as a resource and contact person for active protocols
* Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication
* Successfully integrates the workflow of many studies running simultaneously
* Maintains current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations. and maintains knowledge of current ICH and CFR guidelines
* Assist in training other staff
* Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.

Required Qualifications*

* Bachelor's degree or higher in health science or health-related field
* Four years' previous experience in the conduct of clinical trials
* Certification in related field within 18 months of hire (SoCRA, ACRP, CIP, RAC)
* Strong background and/or experience in clinical research site management, regulatory management and data management
* Excellent written and verbal communication skills
* Strong organizational skills with ability to multitask and prioritize
* Must have exceptional attention to detail and understanding of compliance issues with regard to human subject research
* Outstanding teamwork and customer service orientation
* Ideal candidate will have strong knowledge of 45 CFR part 46 and 21 CFR parts 50
* Travel up to 30% of the time

Desired Qualifications*

* Five to Seven previous experience in the conduct of clinical trials
* Previous therapeutic clinical research monitoring experience
* Previous experience with Epic, MiChart, oncology research
* Certification in related field (SoCRA, ACRP, CIP, RAC)

Work Locations

Free Form

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Job Detail

* Job Opening ID

193602
* Working Title

Site Monitor
* Job Title

Clinical Info Analyst Inter
* Work Location

Multiple Locations

*
* Full/Part Time

Full-Time
* Regular/Temporary

Regular
* FLSA Status

Exempt
* Organizational Group

Medical School
* Department

MM O-CTSU Study CoordMulti
* Posting Begin/End Date

4/21/2021 - 5/05/2021
* Career Interest

Healthcare Admin & Support

Apply Now

Keywords: University Of Michigan, Ann Arbor , Site Monitor, Other , Ann Arbor, Michigan

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