Clinical Research Coordinator - Urology (31159)

JOB TITLE: Research Coordinator
FSLA STATUS: Non-exempt

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 VP of Business Development, CEO, and the physicians at Urology Austin.
• Able to collaborate with experienced patient navigators, IT, and data management.

ROLE QUALIFICATIONS: (experience, education, and skills)
• Must have knowledge of and experience with relevant federal and state regulatory guidelines.
• Must have > 2 years 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.

ESSENTIAL JOB RESPONSIBLITIES:
• 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 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.

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.

REPORTING TO THIS POSITION: No direct reports at this time, can change as department grows.

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.