Shannon Tarr Email & Phone Number

Cleveland, Oh, Us

Somerville, Massachusetts, Us

Real World Evidence Study Manager supporting post-marketing registry operations for gene therapy products.

Novato, California, Us

Clinical operations manager responsible for starting a global, phase III study & an expanded access program supporting the unmet needs of pediatric patients with rare diseases. Responsible for managing cross-functional teams during study start-up, oversight of clinical operations, building study plans, informed consent document management, CRO vendor selection & management. Additionally I served as the clinical lead managing a cross-functional work-stream to create, design, and build an eDiary to capture nutrition, study drug, and patient-reported outcome data to ensure real-time data capture to support primary endpoints.

New York, Ny, Us

Study manager for an esophageal cancer screening study utilizing an esophageal cell capture device and companion diagnostic DNA test. Responsible for site feasibility, selection, initiation. Provided EsoCheck device training for physicians and study staff on the EsoCheck cell capture procedure, EsoGuard DNA collection, clinical trial protocol & subsequent amendments. Additional responsibilities included CRA & CTA management, protocol & EsoCheck training, performing oversight visits, trip report review, approval & mentorship.

Deerfield, Illinois, Us

Senior Regional Site Manager on assignment with Allergan, responsible for managing clinical trial sites throughout the clinical trial process utilizing a Risk-Based Monitoring model. Site management responsibilities included site qualification through site close-out in order to meet the needs of the clinical trial including site feasibility, selection, initiation, training, vendor supply management, and data entry management across various platforms through database lock & study close-out. Therapeutic areas included migraine (acute & chronic), major depression, postoperative atrial fibrillation, and gastroparesis.

Dublin, Ie

Clinical Trial Manager, responsible for two global early-phase oncology & hematology trials.

Dublin, Ie

Site manager overseeing investigational sites for early-phase oncology clinical studies. Independently and proactively coordinated the necessary activities to manage sites and monitor data according to protocol.

Fort Washington, Pa, Us

Senior Site Manager fully dedicated to Merck's early phase oncology trials. Responsible for site selection and monitoring of clinical trial sites in support of the largest phase 1 metastatic melanoma study to receive breakthrough status & US FDA approval based on phase 1 data for KEYTRUDA (pembrolizumab).

Wetzlar, De

Developed Medical Device protocols to support UK (MHRA) & FDA 510K approval for an image analysis workstation specializing in scanning glass slides with digital results for ER, PR, & HER-2 protein expression in breast cancer. Collaborated with cross-functional teams to write study protocols, SOPs, and study plans. Performed site selection & auditing, contract management, budget negotiation & managed logistical planning for importing medical devices to US clinical trial sites. Trained sites on clinical trial requirements, and monitored data according to protocol. Maintained knowledge of current international regulations regarding UK, US FDA, ISO, CAP & CLIA requirements.

Clinical Research Associate monitoring early phase breast & ovarian cancer trials & phase III hypoparathyroidism trials.

Durham, North Carolina, Us

Quintiles US Field Monitoring Group in Collaboration with Lilly Integrated Clinical Operations - Acute Care & Oncology Network Lead Clinical Research Associate for Sarah Cannon Research Institute and a team leader for Acute Care & Oncology Team Training Board responsible for continuing education for therapeutic training in support of Lilly Oncology clinical trials. Performed monitoring site visits, site initiation visits, close-out visits, and site management for a variety of Phase 1 – 3 oncology clinical trial protocols, sites, and therapeutic areas. Maintained quality and integrity within clinical trials related to the proper conduct of the protocol and adherence to applicable regulations by study sites.

Us

Department of Surgery residency research program manager overseeing physician-initiated clinical trials & Department of Anesthesiology clinical trial manager for phase II Sponsor-initiated clinical trials, including post-operative pain management, nausea, and vomiting, with collaborations in the Department of Outcomes Research to observe the long-term effects of anesthesiology on breast cancer recurrence.

Cleveland, Ohio, Us

Research technologist in the Morphologic Molecular Pathology Laboratory

Masters Of Science, Biology

Bachelor'S Of Science, Biology