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Clinical Research Project Manager - Neurology StrokeNet

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Date: Sep 5, 2017

Location: Cincinnati, OH, US

CLINICAL RESEARCH PROJECT MANAGER

NIH STROKENET NATIONAL COORDINATING CENTER

Department of Neurology and Rehabilitation Medicine

University of Cincinnati, College of Medicine

 

The University of Cincinnati is a premier, public, urban research university; ranked as one of America’s top 26 public research universities by the National Science Foundation. U.S. News has ranked UC in the Top Tier of America’s Best Colleges. The Chronicle of Higher Education calls UC a “research heavyweight”. Forbes, Delta Sky and Travel + Leisure magazines have named UC one of the most beautiful campuses. #HottestCollegeInAmerica

 

UC is one of the largest employers in the Cincinnati region, employing over 15,000 full time and part time faculty, staff and student workers. The College of Medicine, Department of Neurology and Rehabilitation Medicine is recruiting for a full-time (100% FTE) NIH StrokeNet National Coordinating Center (NCC) Project Manager.

 

Job Duties and Responsibilities:

  • Collaborate with the PPI, NCC, NDMC and performance site trial team members to ensure successful conduct of clinical trials by managing daily study activities.
  • Interact with clinical site personnel about matters concerning compliance and verification of the trial, FDA and CIRB regulatory requirements, contractual requirements, and shipment and receipt of investigational products. 
  • Track progress and provide authorization to begin site enrollment based on the predefined criteria for each required component of a trial.
  • Maintain database/tracking tools which track site and subject enrollment as well as other elements pertinent to the trial execution.
  • Serve as a liaison between performance site personnel, the PPI, the NCC, and the NDMC trial management teams to enforce adherence to study protocol, the trial MOP, and SAE reporting.
  • Assist in the development and maintenance of the trial MOP.
  • Attend and assist in preparation of DSMB and Trial Investigator meetings.
  • Prepare monthly study update newsletters for participating sites.
  • Assist in the coordination of conference calls, such as the steering, executive, and scientific advisory committees, and face-to-face AHA Conference investigator meetings or other national meetings.
  • Interface with CIRB liaison regarding site CRIB approvals, annual renewals, and reporting of SAEs.  
  • Interface with data management team regarding site and data quality issues.
  • Participate in site initiation visits and staff training as deemed necessary for the trial.

 

Skills and Characteristics Needed:

  • Ability to assist with the coordination of research studies in a particular discipline.
  • Ability to make independent contributions to projects and studies based on professional training or functional experience.
  • Must be able to interact with study sites in a professional manner. 
  • Can accomplish work under general direction.
  • Capable of advising and explaining information to others.
  • Ability to manage moderately complex projects. 
  • Ability to work with the NCC leadership to accomplish the necessary NCC tasks, in addition to short- and long-term goals.
  • Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence.

 

Qualifications and Requirements:

  • Undergraduate degree in natural sciences or an equivalent combination education/experience.
  • At least ten (10) years of work experience, with a Minimum of three (3) years of experience directly involved with clinical research or similar experience in medical field preferred.
  • Proficiency with regulatory guidelines for clinical trials preferred.
  • Proven organizational ability and strong attention to detail.
  • Demonstrates decision-making and problem-solving skills.
  • Excellent time-management skills, communication and interpersonal skills (written and oral), and computer skills including word processing, spreadsheet, and PowerPoint are required.

 

The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.

 

The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.

 

REQ: 21401

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Nearest Major Market: Cincinnati

Job Segment: Medical Technologist, Neurology, Rehabilitation, Clinic, Healthcare, Research

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