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