Site Manager - 119425

Position: Site Manager (Full-Time/Exempt)The Site Manager is responsible for effectively managing day-to-day site activities for optimization of site performance. The Site Manager is responsible for driving the site to achieve company goals. Our clients are twofold, the sponsor and the participant. The Site Manager is responsible for ensuring contractual obligations are met and work is completed in a manner that leads to client satisfaction. Leaders to problem solve issues that may arise that interfere with achieving company goals. It is imperative to represent himself/herself and the site in the most professional, ethical and positive manner. Reports to: Regional DirectorJob Description:Operational PlanningReview and discuss awarded studies with the Principal Investigator to assist Leaders in making informed decisions about what studies to conductWork with Leaders to make informed decisions regarding new staff needs for successful study conductWork with Leaders to ensure site has proper space, staff, and time to optimize study conduct, particularly participant recruitment and retentionClinic Operations Management – Work closely with Leaders regarding staff managementDemonstrate knowledge of research, expectations, and industry standardsLead staff in continued growth and excellent performanceHire quality candidates for positions within the siteEnsure site staff is qualified and trained for roles and dutiesWork with Leaders to plan for upcoming studiesEnsure site staff and investigators are apprised of awarded studiesMonitor staff performance, holding staff accountable to expectations of roleEnsures staff complies with study protocols, FDA regulations, and ICH guidelinesEnsures staff complies with SOPs and other policies and processesMonitor site quality and performance and develop solutions to optimize performanceMonitor study needs and assist staff with study conduct and management, as neededManage staff schedules for optimization of site performanceProvides performance feedback to staffWork with Leaders to manage discipline, as necessary, HR issues, such as misconduct, violations of company policy, office turmoil, etc of coordinating staffEnsure staff compliance with company Employee HandbookInvestigator Relationship– Develop strong working relationships with InvestigatorsEnsure Investigator coverage for optimal site visitsCollaborate with investigator to ensure study successQuality ControlManage site quality control processMonitors adherence to SOPs and takes immediate corrective actions as necessary to ensure complianceMonitors site staff to ensure highest quality performance and adherence to Good Clinical Practice and FDA Regulations and guidance’s. Takes immediate corrective actions as necessary to ensure complianceGeneralServes as team member Communicate effectively and professionally with other team members in a timely mannerRepresent in a professional mannerPromote harmony and professionalism within the workplaceAcquire and maintain the following training: SOPs, processes, and policies – every year or as changes are madeGood Clinical Practice (GCP) – every 2 yearsIATA Shipment of Hazardous Goods – (if applicable) every 3 years, or as directedParticipate in study-specific training as requiredMaintain medical license(s), certifications, etcStudy Coordinating and Recruitment (The following is listed for what is expected of site staff. This is listed here for sites where site managers are coordinating studies)Ensure site is prepared for study conductEnsures appropriate staff attends Investigator meeting and Site Initiation VisitEnsure staff who will be participating on the trial are trained appropriatelyEnsure source creation is completed and reviewed in a timely mannerWork with Regulatory Staff to manage essential documentsComplete site level Regulatory duties, including continuing reviews and study close outsDisseminate information to other personnel, as well as to potential patientsEnsure all staff is trained according to tasks that will be delegatedEnsure site has obtained all required documents and equipment to conduct studyEnsure site has received sponsor and IRB approvalCommunicate with the sponsor in a timely mannerCommunicate with others involved with/in the study, such as vendors, recruiting department and other resources as neededEnsure recruitment goals for all studies are met or exceedEnsure all study-related activities are completed per protocol. FDA regulations, ICH guidelines, and expectationsEnsure information is entered into case report forms completely and accuratelyDevelop relationships and communicate with sponsors and sponsor monitorsEnsure data queries are completed efficientlyEnsure study documents are complete, current and filed correctlyEnsure laboratory procedures are completed accuratelyManage study suppliesEnsure study closeout activities are completed efficientlyOther duties as assignedRequired Skills/Abilities:Must be able to communicate in verbal and written form effectivelyMust be able to read or learn to read scientific language and generalize information Must be willing and able to adhere to instructions and regulationsMust demonstrate leadership skillsEducation and Experience:3+ years’ experience in the Clinical Research IndustrySupervisory/management experience or demonstrated definitive leadership skillsExperience with regulatory processes, clinical procedures, sponsor interaction, and human resources preferredCollege or Specialized Degree preferredPhysical Requirements:Must be able to work remotely and be available during business hoursMust be able to lift up to 15 pounds at timesMust be able to commute between sites in areas with multiple locationsMust be available to travel as needed (<20%)