Serves as a point of contact for clients and may serve as Non-Scientific Board Member. Additionally, exhibits and instills in staff members a customer service and quality focused approach and promotes clients loyalty by providing excellent customer service in the management of study activities.

Provides administrative support to the IRB members, clients, investigators and study personnel.

Provided administrative support to the IRB by assisting int he activities associated with processing study related documents within established turnaround time.

Ensure compliance with Federal Regulations, ICH Guidelines and IntegReview Standard Operating Procedures are followed with the quality assurance of regulatory documents to ensure submissions are complete. Follow-up with physicians/nurses/coordinators/project managers on missing required information that is found during the quality assurance of regulatory documents for submissions to be complete prior to board review for approval. Communicate effectively with clients to identify and resolve issues related to study submissions in a timely manner. Perform quality assurance on study related documents that will become permanent records maintained in the company electronic filing system to ensure accuracy and completeness, prior to shredding. Communicate effectively with other staff members to obtain missing information and/or resolve issues regarding the quality of scanned documents. Prepare and distribute continuing review reminders and forms to investigators, whose IRB approval expiration is upcoming. Perform quality assurance in the preparation and distribution of Project Manager reports to identify completed and incomplete Principal Investigator submissions on a weekly basis. Maintain or improve office efficiencies by working to the best of my ability and suggest process improvements when needed. Assists other team members as needed in other aspects of IntegReview job functions.

Performed quality assurance, data entry, processed and distributed expedited request or full board request, such as revisions to the informed consents, protocol amendments, recruiting materials, adverse event/IND safety reports, significant protocol deviations, notifications of study closure requests and other documents as needed, requests were processed within a 24-hour turnaround time. Interacted directly with physicians/nurses/coordinators/project managers to obtain missing information, resolve issues, and field questions/requests. Assisted clients in completion of required forms for documents submission. Assisted IRB Coordinator/Co-Chairman in activities associated with the planning and follow-up of board meetings, if necessary, assisted the coordinator with revising the informed consents during the board meetings. Performed quality assurance, data entry, and all meeting follow-up for principal investigators going through the continuing review process. With the processing of all documents, complied with Federal Regulations and IntegReview Standard Operating Procedures.

Provided administrative and clerical support to the Clinical Site Operations department; served as liaison for clients and staff. Maintained screening and surgical calendars for bunionectomy procedures for surgeons/clients/staff using Outlook, scheduled between 30-50 surgical procedures per week; coordinated calendars with surgeons/anesthesiology office staff. Using Word and Excel spreadsheets, maintained extensive client/staff files, including all compensation for clients/surgeons. Processed and submitted compensation request to accounts payable for payment to clients/surgeons. Prepared presentation materials and project documents (contracts/financial disclosures) for sponsor/surgeon meetings, took minutes and transcribed dictation. Completed case report forms and assisted with patient care, as needed. Coordinated travel for sponsor/staff for site initiation meetings prior to beginning new protocols. Answered all incoming calls for surgeons/staff/clients. In addition, traveled to new sites in Baltimore, Maryland and Salt Lake City, Utah to train and incorporate office and scheduling procedures to newly opened sites and newly hired team members. As recruiter, telephoned screened clients for participation in bunionectomy studies; communicated with clients through knowledge of study protocol and medical terminology. Created database with inclusion/exclusion questions following protocol for client recruitment. Responsible for meeting established quotas for study enrollment. Maintained a database to track participant population for all studies and to track compensation for clients.