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Clinical Res Project Mgr Hlth
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Position Number: 1786445
Location: Ann Arbor, MI
Position Type: Health - Healthcare Administration

Clinical Res Project Mgr Hlth

Job Opening ID: 183138
Work Location: Ann Arbor Campus
Full Time/Part Time: Full-Time
Regular/Temporary: Regular
FLSA Status: Exempt
Organizational Group: School Dentistry
Department: DENT Clinical Research Center
Posting Begin/End Date: 1/22/2020 1/29/2020
Salary: $60,000.00 $73,000.00
Paid Time Off:
Career Interest: Administration
Healthcare Admin & Support
Research

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.

Mission Statement
MDentistry: advancing health through education, service, research and discovery.

MDentistry Core Values: Compassion, Leadership, Excellence, Responsibility, Trust, Creativity, and Inclusion.

The mission of the University of Michigan is to serve the people of Michigan and the world through preeminence in creating, communicating, preserving and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future. The University of Michigan is committed to foster learning, creativity and productivity, and to support the vigorous exchange of ideas and information, not only in the classroom but in the workplace by: -Creating a work environment in which people treat each other with respect and dignity, regardless of roles, responsibilities or differences. -Providing support, direction and resources enabling us to accomplish the responsibilities of our jobs and to reach the goals that are set for professional and personal growth.

Responsibilities*
The School of Dentistry's Clinical Research Project Manager (CRPM) reports to the Director of the Office of Human and Clinical Research Center (HCRC). This position has the oversight for clinical projects and responsibility for ensuring project completion within specifications. The CRPM assists with project development, establishes operational objectives and assignments; defines and manages project resource needs, timelines and budgets; reporting; and analyzes, compares and evaluates courses of action.

Regulatory Management (Compliance):

Oversight for clinical projects within the School of Dentistry and ensures that the projects have regulatory approval, standard operating procedures, and appropriate project support if needed.
Resource and main point of contact for advising and managing study coordinators and PIs concerning IRB applications including documents such as protocols, ICFs, and recruitment materials schoolwide.
Resource and main point of contact for clinical and study team members concerning institutional guidelines and regulatory issues governing clinical research projects that may require following University, FDA and ICH guidelines and policies.
Manages and advises regarding regulatory binders with study coordinators for multiple studies.
Manage School of Dentistry data in eResearch Regulatory Management.
Serve as the subject matter expert and manages clinicaltrials.gov study information.
Liaison to ORCR, IRB staff, other School of Dentistry department personnel regarding clinical research activities.
Assists with designing source documents, recruitment materials, and other relevant study documents for projects.
As an opt in service for clinical projects aid with clinical research coordination and ensure that regulatory requirements are in place prior to project initiation (IRB approvals, HIPAA, FDA, ICH, standard operating procedures, billing calendars, study budgets, patient consents, execution of study protocol, clinicaltrials.gov study registration, controlled substance management,etc.).
Provides guidance, training, and mentorship to study personnel, students and faculty.
Main contact for training study coordinators at the SoD
Serve as the subject matter expert for Human Subjects Incentive Program (HSIP) at the School of Dentistry which includes ensuring human subject payment compliance and training of SOD staff throughout the school on HSIP requests, distributions, reconciliation and document retention.
Develops Clinical Research related training offerings for the SOD community.
Other duties as assigned.

Administrative Duties:

Assists Clinical Research Director with the creation of a new clinical research unit by evaluating research finances, feasibility of studies and unit infrastructure that supports all clinical research for the School of Dentistry.
Manages the HCRC clinical unit development during the renovation
Supports and partners with the Director of Clinical Research in developing strategic direction for short and long-range objectives.
May represents the HCRC on internal and University committees relating to clinical research issues in support of the Director of Clinical Research
In conjunction with and in support of the Director of Clinical Research manages and develops new processes and policies for research at the SOD (i.e. study database planning and development, develop continuing education seminars related to research).
Establishes, manages and implements changes to clinical and office administration procedures and assignments.
Collects research fee code creation worksheet from PIs and study team for each new clinical study and routes them to the Dental Billing Office for implementation.
Manages the Practice Based Clinical Research Referral Network
Develops manages and maintains metrics for the HCRC
Manages the Clinical Research Coordinator meetings for the dental school
Supports the Director of Clinical Research in the management of the HCRC Advisory Committee
Oversight for the SOD research registry.
Oversight of electronic data storage for completed UMSoD clinical trials
Works with key staff from varying SOD departments to bridge internal functions and create new processes (i.e. Contracts and Grants, CBO, Financial Director, Departmental Administrators and Managers).
Works with varying UM units to bridge SOD research with University research policies (i.e. Regulatory Affairs, IRB, OHRCR, MICHR).
Oversees the management of space and equipment as it relates to the HCRC
Develops and manages all communications for the HCRC which include newsletters, regular emails and other media.
Works in partnership with the Director of Clinical Research and HCRC customers to continuously assesses services offered and makes suggestions for improvements or additions.
Other duties as assigned.

Required Qualifications*
Bachelor's degree with at least 3-5 years experience in clinical research. Demonstrated experience in the management of clinical trials and clinical research projects. Understanding of Good Clinical Practice (GCP), International Council on Harmonisation (ICH) and Food and Drug Administration (FDA) regulations. Professional demeanor with excellent communication skills, including excellent interpersonal communication and writing skills. Confident and highly motivated with excellent record keeping skills. Ability to work both independently and with diverse teams of people in a diplomatic and collaborative environment. Ability to problem solve and establish timelines and priorities. Excellent organizational skills with high attention to detail. Excellent attendance record.

Desired Qualifications*
Advanced degree preferably in a health science discipline. Previous experience in Clinical Research Design and statistical analysis. Experience with Clinicaltrials.gov along with experience with the University's Human Subjects Incentive Program (HSIP). Experience with the University's eResearch Regulatory Management system. Experience with grants and contracts. SOCRA or ACRP certified or a willingness to become certified. Experience in database development and management as well as clinical records software (RedCap, OnCore, Michart, Axium, etc.). Working knowledge of medical and dental terminology and the ability to sustain and high level of organization.

Work Locations
This position is located in the School of Dentistry at 1011 N. University Avenue, Ann Arbor, MI 48109.

Background Screening
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks will be performed in compliance with the Fair Credit Reporting Act.

U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.

To apply, visit https://careers.umich.edu/job_detail/183138/clinical_res_project_mgr_hlth