Regulatory/Recruitment Specialist, Clinical Research Coordinator
University Orthopedics Center, a leading provider of orthopedic services, is currently seeking a full-time Certified Medical Assistant for our Regulatory/Recruitment Specialist, Clinical Research Coordinator position. Position Summary This position will be split 50% of the time as a Regulatory Recruitment Specialist and 50% time as a backup Clinical Research Coordinator (CRC). The individual in this position performs a variety of clinical study activities to assist UOC Clinical Research and the Investigator in the conduct of a clinical trial. Position Requirements: Knowledge in Good Clinical Practices for clinical research Knowledge in Food and Drug Association’s (FDA) regulations and guidelines Current CPR certification/maintenance Certification or willing to become certified in the clinical research field (ACRP) Ability to travel between all UOC Offices as needed; 50% Altoona, 50% State College Prior experience in the medical or health-related field; Certified Medical Assistant or Phlebotomist preferred, but not required. Experienced in venipuncture, capillary puncture, and specimen collection for patients of all ages Trained in proper specimen labeling, handling, and transport to ensure accuracy and compliance with laboratory standards Operational Responsibilities: Conduct all clinical study activities according to FDA regulations and guidelines Ensure the safety and welfare of the study participants. Follow study protocols and schedule patient visits within protocol requirements. Contact and secure vendors needed for each study. Familiar with infection control protocols, HIPAA regulations, and maintaining detailed documentation Study Responsibilities: Schedule meetings with sponsors/monitors and ensure appropriate personnel can attend. Provide and maintain regulatory assistance, including IRB and Sponsor submissions, approvals, closures… Design and maintain organizational tools to conduct the study accurately and in compliance with GCPs and the protocol Maintain knowledge of Protocol and Amendments Train site personnel and medical staff in Protocol Recruit potential study participants according to the protocol’s inclusion and exclusion criteria Maintain adequate and accurate medical charts for each study patient Complete source documents based on protocol. Obtain thorough medical history. Complete Case Report Forms (CRFs) accurately Regulatory Responsibilities: Collect and complete regulatory documents for the Sponsor and Institutional Review Board (IRB) Provide regulatory assistance when needed including, but not limited to safety reports, SAE reporting, additional submissions, approvals, closures… Maintains Study File Binder(s), study start-up materials, and the Trial Master File as needed Update/track providers and staff CV’s, medical license, GCP/CITI training Create source documentation for upcoming studies Recruitment of sponsors and clinical trials Track letters, contacts, emails to sponsors/pharmaceutical companies Maintain spreadsheets of recruitment of patients and studies Run reports of patients for study specific inclusion and exclusion Determine eligibility/prescreen Recruitment of patients Data entry for specific retrospective studies Advertising for current and new studies- social media, all staff emails Submit to UOC newsletter updates for clinical trials department IRB submissions, tracking of continuing reviews, close out submissions Revisions and creating Informed Consent Forms for new studies Tracking patient payments and assuring patients are paid Email communication with research site, staff, and sponsors Will act as unblinded pharmacist as needed Qualifications and Personal Profile: Self-driven; able to initiate and work independently Effective communicator; able to present information to staff and potential patients Positive attitude: ability to work well with others. Adaptable to change and willing to accept added responsibilities and accountability. Reports to: UOC Clinical Research Site Manager Job Type: Full-time Pay: $18.00 - $24.00 per hour Benefits: 401(k) Dental insurance Employee assistance program Employee discount Flexible schedule Free parking Health insurance Health savings account License reimbursement Life insurance Paid time off Referral program Retirement plan Travel reimbursement * Vision insurance Work Location: In person