Clinical Research Coordinator - Urology
Behavioral Health Market Context
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Qualifications
- •Must have knowledge of and experience with relevant federal and state regulatory guidelines
- •Must have > 2 years experience with conducting clinical trials
- •Experience with evaluating and implementing study protocols and budgets
- •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
- •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
- •Ability to use multi-line phone systems and basic computer systems
- •Interpersonal and communication both with internal staff and external customers
- •Skill in evaluating and implementing study protocols and budgets
- •Skill in reading medical chart terminology
- •Time Management
- •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
- •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
- •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
- •17 more items(s)
Responsibilities
- •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
- •Reports to the VP of Business Development, CEO, and the physicians at Urology Austin
- •Able to collaborate with experienced patient navigators, IT, and data management
- •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
- •Work environment: Primarily office setting
- •Noise level in the work environment is usually moderate
- •26 more items(s)
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