CLIN RES MONRING SPEC SR
Duties: The Senior Clinical Research Monitoring Specialist is an integral member of the Office of Clinical Research (OCR) in the Perelman School of Medicine and reports directly to the Director of the Sponsor Support Unit. The Sr. Clinical Research Monitoring Specialist is responsible for performing Good Clinical Practice (GCP) monitoring activities for University or faculty held Investigational New Drug (IND), Investigational Device Exemptions (IDE) and foreign Clinical Trial Applications (CTA) clinical research trials to verify human subjects are protected; the data are accurate, complete, and verifiable from source documents; and the conduct of the trial follows the approved protocol. The Senior Clinical Research Monitoring Specialist will:
* Develop and maintain risk based monitoring plans to ensure quality and integrity of data, protection of human subjects, the trial is conducted in compliance with the study documents, GCP, and applicable regulations.
* Participate in sponsor development meetings and Data Safety Monitoring Board Meetings to review, contribute and present on the progress of ongoing clinical trials.
* Conduct or oversee vendors conducting initial, interim and close out monitoring visits in adherence to: the study-specific data safety monitoring plan (DSMP); protocol; applicable regulatory requirements; Sponsor Standard Operating Procedures (SOPs); and GCP/ICH guidelines.
* Confirm appropriate documentation pertaining to investigational product storage, accountability, administration and chain of custody for each subject and to confirm only enrolled subjects receive investigational product.
* Assess investigator oversight of the trial.
* Perform the PI compliance training and site compliance management. Develop and implement corrective action plans, and communicate progress to Sponsor Regulatory team, and follow-up to ensure appropriate resolution of identified issues.
* Ensure timely development and reporting of monitoring visit reports and follow up letters.
Qualifications: A Bachelor's degree and 5 years to 7 years of experience or equivalent combination of education and experience required. Masters degree preferred. Work experience in clinical/translational research compliance and/or operations in any of the following areas: Academia, Pharmaceutical, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private); Direct experience in the following areas preferred:
Compliance oversight for clinical trials; monitoring or auditing;
Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines;
Ability to respect and protect highly sensitive and confidential information required
Reference Number: 40-28276
Salary Grade: 028
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Job Family: I-Technical/Professional Research