The University of Cincinnati
Cincinnati, OH, United States
Healthcare, Clinical Research, Pharmaceutical, Research, Project Management, Education
Clinical Research Project Manager
Department of Neurology
College of Medicine
The Department of Neurology is hiring a Clinical Research Project Manager to work with the NIH StrokeNet National Coordinating Center.
Duties would include, but are not limited to:
1. Collaborate with the PPI, NCC, NDMC and performance site trial team members to ensure successful conduct of clinical trials by managing daily study activities.
2. 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.
3. Track progress and provide authorization to begin site enrollment based on the predefined criteria for each required component of a trial.
4. Maintain database/tracking tools which track site and subject enrollment as well as other elements pertinent to the trial execution.
5. 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 MOPP, and SAE reporting.
6. Assist in the development and maintenance of the trial MOPP.
7. Attend and assist in preparation of DSMB and Trial Investigator meetings.
8. Prepare monthly study update newsletters for participating sites.
9. Coordinate regular conference calls of steering, executive, and scientific advisory committees and face-to-face AHA Conference investigator meetings or other national meetings.
10. Interface with CIRB liaison regarding site CIRB approvals, annual renewals, and reporting of SAEs.
11. Interface with NDMC data manager regarding site and data quality issues.
12. Participate in site initiation visits and staff training as deemed necessary for the trial.
Minimum Qualifications: Bachelor degree; preferably in related discipline or equivalent education/experience. Five (5) to ten (10) years directly relevant experience; preferably in an academic or clinical setting.
*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.
_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._
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.
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The University of Cincinnati
Website : http://www.uc.edu
The University of Cincinnati offers students a balance of educational excellence and real-world experience. UC is a public research university with an enrollment of more than 43,000 students.