Clinical Research Coordinator
Germantown, TN
Full Time
Clinical
Experienced
Job 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. Will be working in highly motivated large private practice urology group with 30+ providers.
Responsibilities and Duties:
- 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.
Qualifications and Skills:
- 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.
- Clinical experience preferred
- Venipuncture 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.
Urology Austin offers a competitive benefits package to eligible employees. Below are some of the benefits you may receive as an employee at Urology Austin.
- Medical, Dental, and Vision Insurance
- Short & Long Term Disability
- 401(k) with Employer Contributions and Profit Sharing
- Paid Time Off (PTO)
- Group Term Life Insurance
- Health Care & Dependent Care Flexible Spending Accounts
- Health Savings Account
- Employee Assistance Program (EAP)
- Competitive Wages
- Paid Holidays
- No Weekends
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