Clinical Research Regional Manager (Contract)

POSITION DESCRIPTION : The Research Manager reports to the Director and is responsible for the clinical research staff & daily operations at each office.RESPONSIBILITIES : Travels daily to AARA Clinical Research SitesManage and supervise all study coordinators and research assistantsEnsure workloads are balanced among coordinators and assistants in each officeAssign studies and tasks to coordinators and assistantsEnsure all site responsibilities and goals are met, including monthly productivity goals for staff Monitor recruitment efforts and ensure enrollment goals are met in each office. Meet with each staff member monthly for a one-on-one meeting Perform HR responsibilities including interviews, 90 day and annual reviews, reprimands, and terminations for clinical staffEnsure the research clinical staff have the skills and resources necessary for successPerform quality assurance and complete corrective action and prevention assessment plans.Monitor compliance with protocols, policies, standard operating procedures, ICH-GCP Standards, local and FDA regulations and implement solutions to increase compliance as neededEnsure company SOPs and Handbook are followed by research staff and affiliates at all times, including all training and regulatory obligationsMaintain professional and positive work environment for all officesAvailable as an expert resource on all clinical trials and related questions to all staff membersProvide ongoing support, needs assessment, and issue resolution to sites and staff on an ongoing basis, and will escalate to Director if neededPerforms coordinating functions when there is any lapse in coverage at the officesMay coordinate a limited number of clinical trials Participates in the training and mentorship of new staffParticipate in Pre-Study Visits and Site Initiation Visits as neededMeet with administrative staff and department managers regularly to ensure all research operations are running smoothlyCommunicates with clinic staff, vendors, sponsors and CROs as needed to address and resolve outstanding issuesParticipate in ongoing education to remain knowledgeable on all protocols at the institution, staff handbook, standard operating procedures, ICH-GCP regulations, FDA 21 CFR, IRB Guidelines, and all applicable local and federal LawsRequirementsQualifications : Bachelor's Degree or Equivalent4 years' experience in clinical research Clinical Research Certification (CRCC / CCRP)Subject Matter Expert in clinical research and clinical indicationsMust have in-depth knowledge of medical and clinical terminologyExcellent working knowledge of ICH-GCP Guidelines and all Federal regulations regarding clinical researchUnderstands specific state and federal regulations governing medicine and clinical researchPossess strong leadership & organizational skillsAbility to develop and maintain strong professional relationships with all providers and research subjectsMaintains confidentiality of patient and study informationExcellent verbal and written communication skills Ability to lift 20 poundsWilling and able to travel to all offices weeklyManagement experience and / or formal training preferred