Clinical Research Project Manager Healthcare

Location
Michigan,United States
Posted
18 Apr 2019
End of advertisement period
23 Apr 2019
Ref
171168
Contract Type
Permanent
Hours
Full Time

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

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*

The project manager will act as a liaison to the sponsor, regulatory agencies, research subjects, IRB, and investigators.  The project manager is responsible for the general implementation and conduct of clinical trials and investigator initiated studies. This includes: coordinating and overseeing research projects; oversee data entry, management and summary reports; write and/or edit progress reports and technical reports.

  • Manage, supervise, mentor, and develop research coordinator direct reports
  •  Responsibility and oversight for the screening and recruitment of subjects
  •  Lead recruitment teams and various study team meetings
  • Manage onboarding and training of staff direct reports
  •  Lead in the training and development of all research staff members
  •  Manage the collection of data for clinical research projects from various sources.
  • Responsible for overseeing and maintaining records related to the training of research coordinators for all protocols.
  • Oversee clinical research study conduct and address accordingly
  •  Develop and track study timelines, budgets, and quality metrics
  • Develop and optimize recruitment strategies and participant engagement plan
  •  Assess the operational feasibility of clinical studies while providing recommendations for execution and risk mitigation
  • Maintain regulatory and scientific compliance of clinical research studies
  • Establish protocols and operational procedures such as data collection, manual of operations, and study protocols
  • Interact with study teams to ensure complete and accurate study data, adherence to local and federal regulations, and protocol specific instruction.
  • Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to research compliance.

Data Use Agreements/Data Management:

Serve as subject matter expert of Data Use Agreements (DUA)-Maintain inventory of DUA's licenses, and data resources within the division including type of data, areas covered by thedata and years of data, formats, limitations of use agreements.

Serve as subject matter expert in data management activities such as recording the initial receipt of data files and creating pathways for the management and handling of data into (SAS, STATA, etc.), standardization of multiple years of data sets andmaintenance of data documentation and data dictionaries/code books.-Assist in the development of data management plans pertaining to data security and protection of the data (with HITS,executive management, compliance and others)-Facilitate sharing and distribution of data resources (according to DUA limitation and use agreement limitations) includingdevelopment of efficient means of sharing data without duplication of data.-Work with units/centers to identify the data resources needed and means for either reuse of data or facilitating purchase ofnew data (including sharing costs for multiple users)-Work with HITS and other campus IT providers to request secure file storage and access systems such that users haveaccess to the data needed.-Interface with the Data Office for Clinical and Translational Research

Required Qualifications*

  • Bachelor's degree in business or related healthcare or science field
  • At least 3 years’ experience in clinical research
  • Experience in research and clinical study regulation and compliance, operations management, and scientific writing
  • Ability to be consistently detail-oriented
  • Excellent communication, both oral and written, and interpersonal skills
  • Ability to prioritize, organize, and efficiently work on multiple projects at the same time
  • Ability to work independently and meet deadlines
  • Excellent interpersonal, oral, and written communication skills
  • Demonstrated ability to work effectively with physicians, researchers, peers, administrators, and staff of all disciplines to enhance and improve the research experience
  • Demonstrated ability to collaborate in a manner that fosters team building and provides direction for team members 

Desired Qualifications*

  • Knowledge of the University of Michigan IRB process
  • Master's degree preferred
  • Certified Research Administrator (CRA)
  • Knowledge of hospital and medical center policies and procedures     

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.