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Clinical Research Coordinator
Clinical Research CoordinatorUrology America, MSO • Austin, TX, US
Clinical Research Coordinator

Clinical Research Coordinator

Urology America, MSO • Austin, TX, US
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Position Summary :

  • Experienced Research Coordinator needed to continue building and lead a newly growing research department.
  • Will have the opportunity to help create a premier research facility.
  • We will provide the necessary support, budget, staff, etc.
  • You would work closely with our PI and Sub-Is on the various studies.
  • Will be working in highly motivated large private practice urology group with 30+ providers.

Job Relationships :

  • Reports to the Research Manager Collaborates with experienced patient navigators, IT, data management, and Urology America clinical research staff.

    • Qualifications :

  • Must have knowledge of and experience with relevant federal and state regulatory guidelines.
  • Must have >

    • 5yrs experience with conducting clinical trials.

  • Urology based clinical experience preferred.
  • Experience with evaluating and implementing study protocols and budgets.
  • Certification via ACRP or the equivalent preferred.
  • Proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems.
  • Effective time management and the ability to prioritize work.
  • Excellent communication skills and the ability to interact with all levels of management, staff, and physicians.

    • Key Responsibilities :

  • Work to build the research department in scope, size, reputation, and professionalism.
  • Assist with recruitment of studies, budget evaluation and negotiation, protocol evaluation, communication with study sponsors.
  • Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.
  • Obtain and maintain consent of patients with the highest ethical standards.
  • Work with other research department staff in a leadership role including management, training, delegation of responsibilities, hiring, etc.
  • Work directly with patients to screen, 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, find patients, maintain records.
  • Must have or gain knowledge of relevant software / 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 necessary meetings and calls.
  • Create and maintain department SOPs, NDAs, CVs, certifications, etc.
  • Evaluate, purchase, maintain necessary equipment. ]Maintain HIPAA compliant communication and confidentiality, at all times.
  • Maintain study budgets and monitor invoicing, billing, and payments.
  • Participate in site visits, SIVs, monitoring, etc.
  • Complete necessary study close-out steps and documentation.
  • Assist with other duties assigned.

    • Performance Requirements :

  • Knowledge Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.
  • Understanding of medical terminology.
  • Skills Ability to use multi-line phone systems and basic computer systems.
  • Interpersonal communication with internal staff and external customers.
  • Skill in evaluating and implementing study protocols and budgets.
  • Skill in reading medical chart terminology.
  • Time Management.
  • Abilities Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.
  • Elicit appropriate information for patients to clinic staff.
  • Ability to read and understand information and ideas presented in writing.

    • Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.

    Physical Demands and Work Environment :

  • The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job.

    • Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions :

  • Physical demands : Involves sitting approximately 90 percent of the day, walking or standing for the remainder.
  • Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.

    • Work environment :

  • Primarily office setting.
  • Noise level in the work environment is usually moderate.
  • Clean, well-lighted office environment.
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