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Clinical Research Manager

Job Description

LOCATION:  Homewood

SUPERVISED BY: Chief Executive Officer

BASIC 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 years’ 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:
• BCLS certified
• CCRC
• Employee Training and Management
• Venipuncture
• Physical assessment skills
• Chart review
• Technical skills that can be flexibly adapted to accommodate prospective studies
• Excellent patient relation skills
• Excellent organizational skills
• Excellent Multi-tasking
• Proficient with Microsoft Word and Excel
• IATA Certified
• GCP and NIH certified

RESPONSIBILITIES:
• Markets Urology Centers of Alabama, P.C. to Pharmaceutical companies, CRO, Sponsors and Medical device companies for prospective research studies.
• Market on Social Media
• Reviews potential protocols from pharmaceutical and/or medical device companies for acceptability, feasibility and facility requirements.
• Generates and negotiates a budget for each study and submits it to the sponsor or Contract Research Organization (CRO) for approval.
• Negotiates contracts for all 3rd party vendors.
• Sponsor and CRO Contract Review and negotiations.
• Invoice submission
• Vendor Payment
• Checks and Balances each trial payment
• Maintains financial records throughout each study
• Balances all payments with each visit for each patient
• Provides periodic financial status reports to the PI, Sub-investigators and Director.
• Attends and participates in Investigator meetings and seminars as needed (usually requires overnight travel).
• Maintains continuing education requirements to maintain nursing licensure.
• Creates, maintains, and updates Standard Operational Procedures.
• Trains all staff on new SOP procedures
• Organizes marketing efforts, promotional measures, advertisements, etc., to obtain patient recruitment for each study.
• Assists Coordinators in identifying and pre-screening potential patients for studies.
• Educates physicians and nursing personnel updated regarding currently enrolling protocols (i.e. inclusion/exclusion requirements)
• Develops patient information tools to ensure patient understanding and compliance of medications, adverse events.
• Develops visit worksheets (source documents) to ensure complete and accurate collection of data.
• 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.
• Ensures maintenance of accurate overall study drug accountability records (receipt, storage and dispensing).
• Conducts site visits with study sponsor or CRO monitors.
• Ensures that discrepancies found by the monitors are corrected in a timely fashion.
• Maintains written records of all phone conversations with Sponsor, CROs, monitors, IRB, lab, etc. during the study.
• Acts as liaison between the site and the Sponsor and/or CRO.
• Reviews research journals and pertinent publications in order to stay informed of current research issues.
• Coordinates activities of associates to ensure compliance with protocol
• 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.
• Advanced planning and risk management for projects
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• Provide consultation to monitors in interpretation of audit observations and formulation of corrective action plans
• Prepare, review and approve corrective action plans
• Present educational programs and provide guidance to operational staff on compliance procedures
• Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Host audit as need by the FDA or IRB
• Complete and Submit all initial start-up Documents to CRO and IRB
• Review and maintain contracts between Brookwood outpatient services, Birmingham news, and other outside vendors
• IRB submissions for Central and Local IRB’s and ECOG trials.
• IRB yearly reviews, and Close-out reports
• Maintenance of Regulatory Binders
• Filing of all documents in regulatory binders
• IRB submission of SAE forms
• Maintenance and storage of all closed studies
• Calibration maintenance of all Research equipment
• Ordering supplies
• Protocol development and compliance for Investigator initiated studies
• Completion and submission of all initial regulatory documents (including sponsor and IRB documents) for multiple sites / multiples MDs and maintenance of regulatory files.
• Correspondence with Institutional Review Boards, Pharmaceutical Companies and CROs regarding regulatory documents and financial information.
• Quality Assurance for Regulatory, Case Report Form (CRF) and Source Document completion for all studies
• Maintain FDA, GCP and NIH compliance
• Facilitates yearly training for all Coordinators, Data managers, Principal Investigators, and Sub-Investigators
• Conducts weekly staff meeting
• Attend monthly Tumor Board Meetings
• Attend and Participate in the development of the APCC clinic
• Employee time, vacation, and sick time management
• Employee evaluations, discipline, encouragement, education and growth
• Dailey supervision of Research Staff
• On-Call duty to be available to all research patients that require assistance afterhours
• Attends regular conference calls and training sessions for all on-going trials
• Generates reports within Greenway for subject recruitment
• Attend all regular meetings with Sponsor and CRO’s to include Pre-site, Initiation, interim and close-out visits
• Attend yearly conference with the ACRP to network for Urology Centers of Alabama
• Attend monthly managers meetings
• Maintains open communication between Research Staff and Clinic Staff
• Create new ways to involve the Clinic Staff, Front Office Staff, Lab Techs, and Physicians with the Research Department.
• Act as a Back-up Coordinator and Back-up Data Manager
• Maintains all written documentation between CROs, Sponsors, IRB, FDA, Lab and other parties associated with Research
• Attend teleconferences and training sessions for each of the protocols
• Completes Training for E-CRF and IVRS systems

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