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Clinical Research Manager

Location
Homewood, AL

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Job DescriptionBASIC DESCRIPTION:Expanding Practice Based Research Facility in Birmingham, AL is looking for a Clinical Research Manager to fill a Full-Time Position for conducting specialty/phase clinical research trials. Must have minimum two year of 4 yearsu2019 experience with clinical and financial management relating to clinical research. Skills must include overall research management including budgets, contracts, human resources, software management, the ability to complete patient visits according to protocol, interact with patients, and additionally be well-organized and detail-oriented. The Clinical Research Manager must also, understand HIPAA and the Informed Consent process. Proficient Microsoft Office, Word, and electronic data capture is required. The ability to multi-task and maintain multiple studies is an essential requirement. CCRC Certification is required.QUALIFICATIONS:u2022 BCLS certifiedu2022 CCRCu2022 Employee Training and Managementu2022 Venipunctureu2022 Physical assessment skillsu2022 Chart reviewu2022 Technical skills that can be flexibly adapted to accommodate prospective studiesu2022 Excellent patient relation skillsu2022 Excellent organizational skillsu2022 Excellent Multi-taskingu2022 Proficient with Microsoft Word and Excelu2022 IATA Certifiedu2022 GCP and NIH certifiedRESPONSIBILITIES:u2022 Markets **MEMBERS ONLY**SIGN UP NOW***., P.C. to Pharmaceutical companies, CRO, Sponsors and Medical device companies for prospective research studies.u2022 Market on Social Mediau2022 Reviews potential protocols from pharmaceutical and/or medical device companies for acceptability, feasibility and facility requirements.u2022 Generates and negotiates a budget for each study and submits it to the sponsor or Contract Research Organization (CRO) for approval.u2022 Negotiates contracts for all 3rd party vendors.u2022 Sponsor and CRO Contract Review and negotiations.u2022 Invoice submissionu2022 Vendor Paymentu2022 Checks and Balances each trial paymentu2022 Maintains financial records throughout each studyu2022 Balances all payments with each visit for each patientu2022 Provides periodic financial status reports to the PI, Sub-investigators and Director.u2022 Attends and participates in Investigator meetings and seminars as needed (usually requires overnight travel).u2022 Maintains continuing education requirements to maintain nursing licensure.u2022 Creates, maintains, and updates Standard Operational Procedures.u2022 Trains all staff on new SOP proceduresu2022 Organizes marketing efforts, promotional measures, advertisements, etc., to obtain patient recruitment for each study.u2022 Assists Coordinators in identifying and pre-screening potential patients for studies.u2022 Educates physicians and nursing personnel updated regarding currently enrolling protocols (i.e. inclusion/exclusion requirements)u2022 Develops patient information tools to ensure patient understanding and compliance of medications, adverse events.u2022 Develops visit worksheets (source documents) to ensure complete and accurate collection of data.u2022 Ensures adherence to Study Protocol, prevention of unauthorized protocol deviations, and compliance with FDA rules and guidelines for research studies by: (1) training other research personnel and (2) reviewing data as necessary.u2022 Ensures maintenance of accurate overall study drug accountability records (receipt, storage and dispensing).u2022 Conducts site visits with study sponsor or CRO monitors.u2022 Ensures that discrepancies found by the monitors are corrected in a timely fashion.u2022 Maintains written records of all phone conversations with Sponsor, CROs, monitors, IRB, lab, etc. during the study.u2022 Acts as liaison between the site and the Sponsor and/or CRO.u2022 Reviews research journals and pertinent publications in order to stay informed of current research issues.u2022 Coordinates activities of associates to ensure compliance with protocolu2022 Maintain financial files for all studies on computer in Excel (keep track of payments owed to company and to individual investigators based on enrollment and ongoing patient visits), track payments for ongoing enrollment, advertising, remote data entry phone lines, etc.u2022 Advanced planning and risk management for projectsu2022 Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.u2022 Provide consultation to monitors in interpretation of audit observations and formulation of corrective action plansu2022 Prepare, review and approve corrective action plansu2022 Present educational programs and provide guidance to operational staff on compliance proceduresu2022 Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.u2022 Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.u2022 Host audit as need by the FDA or IRBu2022 Complete and Submit all initial start-up Documents to CRO and IRBu2022 Review and maintain contracts between Brookwood outpatient services, Birmingham news, and other outside vendorsu2022 IRB submissions for Central and Local IRBu2019s and ECOG trials.u2022 IRB yearly reviews, and Close-out reportsu2022 Maintenance of Regulatory Bindersu2022 Filing of all documents in regulatory bindersu2022 IRB submission of SAE formsu2022 Maintenance and storage of all closed studiesu2022 Calibration maintenance of all Research equipmentu2022 Ordering suppliesu2022 Protocol development and compliance for Investigator initiated studiesu2022 Completion and submission of all initial regulatory documents (including sponsor and IRB documents) for multiple sites / multiples MDs and maintenance of regulatory files.u2022 Correspondence with Institutional Review Boards, Pharmaceutical Companies and CROs regarding regulatory documents and financial information.u2022 Quality Assurance for Regulatory, Case Report Form (CRF) and Source Document completion for all studiesu2022 Maintain FDA, GCP and NIH complianceu2022 Facilitates yearly training for all Coordinators, Data managers, Principal Investigators, and Sub-Investigatorsu2022 Conducts weekly staff meetingu2022 Attend monthly Tumor Board Meetingsu2022 Attend and Participate in the development of the APCC clinicu2022 Employee time, vacation, and sick time managementu2022 Employee evaluations, discipline, encouragement, education and growthu2022 Dailey supervision of Research Staffu2022 On-Call duty to be available to all research patients that require assistance afterhoursu2022 Attends regular conference calls and training sessions for all on-going trialsu2022 Generates reports within Greenway for subject recruitmentu2022 Attend all regular meetings with Sponsor and CROu2019s to include Pre-site, Initiation, interim and close-out visitsu2022 Attend yearly conference with the ACRP to network for **MEMBERS ONLY**SIGN UP NOW***.u2022 Attend monthly managers meetingsu2022 Maintains open communication between Research Staff and Clinic Staffu2022 Create new ways to involve the Clinic Staff, Front Office Staff, Lab Techs, and Physicians with the Research Department.u2022 Act as a Back-up Coordinator and Back-up Data Manageru2022 Maintains all written documentation between CROs, Sponsors, IRB, FDA, Lab and other parties associated with Researchu2022 Attend teleconferences and training sessions for each of the protocolsu2022 Completes Training for E-CRF and IVRS systems

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