Clinical Research Coordinator

GENERAL DESCRIPTION

The Clinical Research Coordinator will be responsible for the oversite of research projects. In addition, the Clinical Research Coordinator must be able to provide efficient services to our physicians as well as provide quality, courteous and compassionate services to our patients in adherence to the guidelines, policies and procedures set forth by Urology Associates.

• Develop the research department in scope, size, reputation and professionalism.
• Assist with the recruitment of studies, budget evaluation and negotiation, protocol evaluation and communication with study sponsors.
• Maintain certifications in, and continually update knowledge of FDA, GCP, ICH, federal and state regulations, etc.
• Obtain and maintain patient consent with the highest ethical standards.
• Work with staff including management in a leadership role in areas such as training, delegating responsibilities, etc.
• Work directly with patients for screening, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc.
• Communicate with and support patients and their families as necessary.
• Work with the EMR and data management systems to complete EDC, eCRFs, locate patients and maintain records.
• Must have the ability to gain knowledge of relevant software and programs.
• Have a basic and working knowledge of trial design, statistical methods, etc.
• Triage, record and report adverse events.
• Record and report any protocol deviations.
• Work closely with IRB and study sponsors, PIs and Sub-Is.
• Attend meetings and calls.
• Create and maintain department SOPs, NDAs, CVs, certifications, etc.
• Evaluate, purchase and maintain necessary equipment.
• Maintain study budgets and monitor invoicing, billing, and payments.
• Participate in site visits, SIVs, monitoring, etc.
• Complete necessary study close-out steps and documentation.
• Communicate regularly with supervisor, keeping him/her apprised of all pertinent information and providing feedback.
• Ensure compliance for all regulatory requirements including OSHA, CLIA and HIPAA; immediately and accurately document and report occurrences to supervisor; and ensure compliance with all legal and regulatory requirements as outlined in the corporate compliance plan.
• Support and adhere to all company policies, procedures and management decisions; maintain confidentiality of patients’ medical information; and all confidential administrative related issues.
• Demonstrate dependability in attendance, punctuality in reporting for work and initiative in completing a full work schedule; meeting or exceeding all established deadlines and utilizing all resources and supplies efficiently and appropriately.
• Demonstrate the ability to concentrate during the course of the day.
• Display a positive outlook with a helpful, constructive manner when working with other employees.
• Demonstrate superior patient relations and interpersonal skills; demonstrate an appropriate level of mental and emotional tolerance and even temperament when dealing with staff, patients and general public using tact, sensitivity and sound judgment; promote a positive work environment and contribute to the overall efforts of the department and the company.

• Must have knowledge of and experience with relevant federal and state regulatory guidelines.
• Must have a minimum of two (2) years of experience with conducting clinical trials.
• Urology based clinical experience is preferred.
• Experience with evaluating and implementing study protocols and budgets.
• Certification by ACRP or an equivalent is preferred.
• Proficiency in computer software to include Microsoft Office, EMR and Practice Management systems.
• Ability to plan, schedule, prioritize and complete multiple tasks and demands is required
• Excellent oral and written communication, interpersonal, problem-solving and organizational skills are required.
• Occasional overtime, evening and weekend work is required.
• A valid driver’s license, dependable automobile and current auto insurance are…