Clinical Research Project Manager Healthcare

University Of Michigan Ann Arbor , MI 48103

Posted 11 months ago

Clicking "Apply Now" opens the link in a new window. 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 the

data 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 and

maintenance 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) including

development 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 of

new 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 have

access 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.

Job Detail

  • Job Opening ID 171168

  • Working Title Clinical Research Project Manager Healthcare

  • Job Title Clinical Res Project Mgr Hlth

  • Work Location Ann Arbor Campus

Ann Arbor, MI

  • Full/Part Time Full-Time

  • Regular/Temporary Regular

  • FLSA Status Exempt

  • Organizational Group Medical School

  • Department Anesthesiology Department

  • Posting Begin/End Date 4/16/2019 4/23/2019

  • Career Interest Research

Apply Now


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Research Project Coordinator

University Of Michigan

Posted Yesterday

VIEW JOBS 2/18/2020 12:00:00 AM 2020-05-18T00:00 Clicking "Apply Now" opens the link in a new window. 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 Clinical Research Project Coordinator will be working on a new clinical research study that is part of the Precision Health initiative at the University of Michigan. This project is focused on the effects of wearable and mobile technology on mental health outcomes. The project's goals are to reduce the burden of depression and other mental health conditions via mobile technology-delivered interventions, as well as to accelerate recovery from mental illness by better matching pharmacological, psychological, and mobile-based treatments to patients. 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 Clinical Research Project Coordinator will be responsible for helping to manage participant recruitment and follow-up for the project, including obtaining informed consent. This candidate will also help to manage staff recruitment schedules and will offer solutions for challenges that arise during recruitment. The candidate will be managing the many technological components of the study, including set-up, troubleshooting, and support for mobile technology, apps, and online surveys. Completion of research administration tasks is a requirement, including database management, participant tracking, managing participant payments, mailings, and helping with establishing and managing relationships and workflows with project collaborators. The Clinical Research Project Coordinator will also participate in and occasionally lead team meetings, as well as having additional study tasks assigned as needed. Required Qualifications* Bachelor's degree in Social Work, Psychology, or a similar discipline is required, with evidence of course work or experience in research methods and working in a health care/clinical setting. The applicant should possess the ability to configure, explain, and troubleshoot technology (e.g. apps, mobile technology) with both team members and participants, which requires strong problem-solving and communication skills. Excellent organizational skills, professionalism, attention to detail, ability to work independently but also within a team, personable nature, and the ability to prioritize multiple tasks and meet deadlines are all a must. The candidate must be able to work independently for extended periods while receiving feedback and guidance from study coordinators and faculty investigators. Experience working on a multi-disciplinary team and ability to adhere to strict confidentiality guidelines are also a necessity. Experience using MS Excel, Access, REDCap, or NVIVO is preferred. The candidate for this position must be able to: 1) work well independently; 2) work flexible hours to accommodate participant scheduling at the study sites; 3) adhere to strict confidentiality guidelines; 4) demonstrate a strong ability to establish rapport with participants by phone, electronic methods, and in person; 5) demonstrate a strong ability to keep accurate and detailed records of all study procedures; and 6) handle crisis situations including suicidal and/or homicidal participants at the study site in consultation with other study team members. Desired Qualifications* Master's degree in Social Work, Psychology, or a similar discipline is desired. Experience accessing/abstracting medical record data from MiChart/Epic/Electronic Health Records is also preferred. Previous experience conducting health-related research or with substance abuse or high-risk populations is preferred, but not required. The position will require flexibility in order to meet project deadlines and goals; therefore, a strong ability to problem-solve and prioritize is highly desired. Work Schedule This position is full-time, 40 hours/week. Hours are typically regular business hours, Monday-Friday. Some flexible scheduling may be required to allow for participant recruitment and follow-up needs. Work Locations Variable. Participants are recruited from Michigan Medicine Outpatient Psychiatry (Rachel Upjohn Building) and University Health Service. Recruitment takes place largely by phone and electronic methods; however, this candidate may need to meet participants in clinic or in community-based locations for enrollment and technical support. 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. E-Verify The University of Michigan participates with the federal EVerify system. Individuals hired into positions that are funded by a federal contract with the FAR EVerify clause must have their identity and work eligibility confirmed by the EVerify system. This position is identified as a position that may include the EVerify requirement. U-M EEO/AA Statement The University of Michigan is an equal opportunity/affirmative action employer. Job Detail * Job Opening ID 184517 * Working Title Clinical Research Project Coordinator * Job Title Clinical Res Coordinator Hlth * Work Location Ann Arbor Campus Ann Arbor, MI * Full/Part Time Full-Time * Regular/Temporary Regular * FLSA Status Exempt * Organizational Group Medical School * Department Anesthesiology Department * Posting Begin/End Date 2/14/2020 – 2/21/2020 * Career Interest Research Apply Now University Of Michigan Ann Arbor MI

Clinical Research Project Manager Healthcare

University Of Michigan