Clinical Research Coordinator

Urology Associates, P.C., in Nashville, TN, is looking for a qualified candidate with at least 1-2 years of experience in a Clinical Research Department setting to join our robust Clinical Research Department within our private urology clinic as a Clinical Research Coordinator (CRC).

Clinical Research Coordinator A Clinical Research Coordinator (CRC) manages the daily operations of clinical trials in urology oncology specializing in bladder cancer, prostate cancer, and renal cancers. Under the direction of the Principal Investigator (PI) and/or Regulatory Manager, the CRC ensures strict adherence to research protocols, regulating requirements, and Good Clinical Practice (GCP) guidelines throughout the lifecycle of multiple clinical trials.

Core Responsibilities

• Conduct urinary instillations per protocol, administering intravesical therapeutics or facilitating local drug delivery.
• Perform urinalysis during study visits to detect hematuria, infections, and other key abnormalities, ensuring proper collection, timing, and documentation.
• Collect Electronic Patient Reported Outcomes (ePRO) including assessments such as EORTC QLQ-C30, PGI-S, EQ-5D-5L, and EORTC QLQ-NMIBC24 to monitor symptoms, side effects, functional status, and quality of life.
• Perform catheterizations (insertion and care) for diagnostic, therapy, or sample collection, particularly in patients with urinary retention or post intervention.
• Act as liaise with multidisciplinary clinical teams to ensure comprehensive patient follow-up and support.
• Manage communication regarding Adverse Events (AE) and Serious Adverse Events (SAE), ensuring timely reporting according to the IRB and sponsor requirements.
• Maintain source documents, including laboratory and imaging reports, to verify clinical data accuracy.
• Complete Case Report Forms (CRFs) and resolve data queries in collaboration with the monitors and sponsor.

During Study Responsibilities

• Administering study interventions and investigational products per protocol guidelines.
• Review concomitant medications and assess for safety and potential drug interactions.
• Conduct informed consent discussions, explain study objectives, procedures, and risks, and uphold HIPAA privacy standards.
• Collect, enter, and manage research data within Electronic Data Capture (EDC) systems and maintain study databases across multiple trials.
• Participate in monthly Regulatory Department meetings and attend study specific Site Initiation Visits (SIVs) as required.
• Assist with departmental projects and special assignments as requested by the Research Department.
• Schedule imaging exams such as CT scans, or MR Urograms.

Regulatory Compliance

• Maintenance regulatory documentation in accordance with sponsor, FDA, and federal regulations.
• Ensure study procedures comply with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and all regulatory standards.
• Prepare for and support audits, monitoring visits, and regulatory inspections.

Quality Control

• Perform quality checks on study data to identify and resolve discrepancies.
• Facilitate preparation for inspections and compliance reviews by sponsors and regulatory agencies.

Qualifications

• Bachelor’s degree in health sciences, life sciences, or related field is preferred.
• 1 to 2 years of clinical research or related experience, specifically in oncology or urology research is highly advantageous.
• Knowledge of FDA regulations, GCP guidelines, ICH standards.
• Experience with performing laboratory tests such as blood draws, vitals, urinalysis, EKGs, IVs, and additional tasks as defined by the sponsor.
• Strong attention to detail and excellent problem solving skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Physical Demands and Work Environment

• Extended periods of standing, walking, and sitting, combined with typical office work involving computers and electronic data systems.
• The work environment is primarily office-based, with regular use of computers, electronic databases, and standard office equipment.

Work Schedule

• This is a full-time, weekday position with no weekend work required.
• Standard work hours are 7:00 a.m. to 4:00 p.m. or 8:00 a.m. to 5:00 p.m., with a 1-hour lunch break (adjustable with a 30-minute lunch).

UA also offers a fantastic Benefits Package:

• Competitive Salary and Benefits
• Company Paid Holidays (Memorial Day, Fourth of July, Labor Day, Thanksgiving, Black Friday, Christmas Eve, Christmas Day & New Year's Day)
• Vacation and Sick Time, Plus 2 Personal Days a Year
• Medical and Vision Insurance
• Dental Insurance
• Basic Life Insurance (Company Paid!)
• Long-Term Disability Insurance (Company Paid!)
• Optional Short-Term Disability
• Optional Additional Life Insurance for Employee and/or Family Members
• Health Savings Account options, including Employer Contributions!!
• 8% Profit Sharing Contribution to your Retirement Account (Company Paid!)
• Employer Match for Retiring Savings! (We'll match 3.2% if you put in 4%.)
• Employee Assistance Program with Mental Health Benefits through The Hartford (Company Paid!)
• Lots More Benefits such as:
• International Travel Insurance through The Hartford
• Gym Membership Discount through BCBS of TN
• Discount on Verizon phone coverage, simply for working here!
• Massage Membership Discount through BCBS of TN
• Access to PhysicianNow--a TeleHealth healthcare service through BCBS of TN
• Tuition Discounts through BCBS of TN

If you meet the above description and want to continue your career in a market-leading healthcare office, we'd love to hear from you. Please send us your resume today. We hope to fill this position as soon as possible, so don't hesitate! Best of luck to you, and have a fantastic day!

Please note: Job offers are contingent upon a clear background check and drug screen.