Job Purpose:

Responsible for overall leadership and direction of all clinical research operations including but not limited to fiscal management, study and site operations, Program Development, Regulatory, and Patient Recruitment. The Research Coordinator is responsible for developing strategies, plans and managing clinical studies at Cancer Care of North Florida. Ensure compliance with local and federal regulations. Responsible for coordinating the conduct of clinical drug studies from pre-planning through successful completion of all patient visits and documentation. 

Duties:

• Provide clinical oversight and direction to the execution of trials.
• Assess organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures.
• Meets with vendors and physicians as needed to ensure services are being provided.
• Coordinates and schedules Site Selection, Study Initiation, Monitoring and Study Close-out visits.
• Keep Cancer Care of North Florida management team abreast of issues, progress, and risks related to trial operations.
• Oversee all aspects of patient treatment associated with trial execution including: enrollment, patient consent, lab work, drug distribution, pharmacy.
• Ensure general inquiries from current and prospective patients, sponsors, and physicians are appropriately routed and completed in a timely manner.
• Develop clinical research operations budget, monitor expenses and stay within budget.
• Assess and handle all EMR and Computer System issues (ensure compliance with CFR Part 11).
• Evaluate, create and maintain all Cancer Care of North Florida Clinical Research SOPs.
• Create and maintain all research personnel curriculum vitaes. Obtain licenses (renewals) for Cancer Care of North Florida Research Personnel.
• Obtain updated licenses/certificates/reference ranges from laboratories that are used in a clinical study.
• Evaluate study feasibility. Complete feasibility questionnaires.
• Answer phone messages and e-mails in a timely manner documenting communication as necessary.
• Plans and designs new forms/flowsheets/source documents to be used in research activities.
• Coordinates in-service/training/proctoring for physicians, departments and appropriate staff.
• Prepare for audit and meet with auditors (FDA, IRB, Sponsor, etc.). Construct and implement a Corrective Action and Preventative Action Plan for any audit findings. Draft formal response to auditors.
• Maintain a high level of knowledge and understanding of assigned protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information and drug accountability requirements.
• Responsible for completion of all study documentation forms, including case report forms and other study specific documents.
• Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the clinical protocol.
• Review all source documentation and CRF’s for accuracy.
• Interact with Principal Investigator as needed to assure patient receives appropriate medical evaluation and care when needed, alerts Principal Investigator of serious adverse events.
• Interacts with sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process.
• Attends sponsor Investigator/Study Coordinator meetings and attends conference calls as needed for assigned protocols.
• Conducts clinical research in compliance with all applicable regulations.
• Maintains study information: set up and maintain project files, and submit IRB (Investigational Review Board) reports.
• Ensure the prompt follow-up and resolution of all data queries; plan and coordinate data collection and retrieval.
• Ensure the appropriate and timely disbursement of payments to outside contract vendors.
• Serve as liaison between principal investigator, site director, vendors, regional monitors, auditors and clinical research organizations.
• Assist in ongoing review of all Adverse and Serious Adverse Events.
• Assist in tracking, communicating and processing of all drug deliveries.
• Perform various clerical duties (filing, mailings, faxing, creating site files, etc).

Qualifications and Education Requirements:

• RN and/or experienced CRC (preferably CCRC)
• Proficient in Microsoft Word, Excel, and Outlook
• Experience in clinical trial start up, following GCP and OHRP guidelines, SOP and practice development
• Knowledge of industry regulations

Preferred Skills:

• Displays a friendly, professional and courteous manner at all times when interacting with customers or facility personnel.
• Able to organize tasks and time to ensure completion of all duties.
• Able to deal appropriately with confidential information.
• Excellent written and verbal communication skills.
• History of problem solving and solution implementation.
• Ability to work well with co-workers, peers, monitors and potential subjects.
• Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adhere to sponsor requirements.
• Self-motivator, able to work with minimal supervision.
• Ability to pay attention to detail and follow protocol guidelines without deviations.

Required Competencies:

Excellent judgment, dependability, conscientious performance.  Detail oriented.  Exceptional interpersonal and communication skills.  Caring and empathetic.  High ethical standards. Mechanical ability and manual dexterity for operating complicated equipment.