Cimplify→
Clinical Research Coordinator (CRC) at Cimplify in Nashville, TN
Job Description
- Employee Type: Full Time Hourly
- Required Degree: 4 Year Degree
- Minimum Experience: 1 Year
Description
Urology Associates, P.C. - Nashville, TN (Charlotte Clinic) has immediate need for experienced Clinical Research Coordinators (CRC) to join their Clinical Research Department.
The Clinical Research Coordinator (CRC) is the operational owner of day-to-day clinical trial conduct at Urology Associates, P.C. The CRC manages the participant-facing and data-facing work of assigned protocols - recruitment, informed consent support, study visits, protocol-specific assessments, source documentation, and data entry - under the direction of the Principal Investigator (PI) and Clinical Research Department Manager. The CRC ensures every study visit and every data point is conducted ethically, documented accurately, and defensible in an audit.
Requirements
KEY RESPONSIBILITIES
Participant & Visit Management
- Screen, recruit, and consent research participants in accordance with protocol eligibility criteria and IRB-approved informed consent procedures.
- Explain study objectives, procedures, risks, and expectations to participants in clear, understandable terms; address ongoing participant questions and concerns.
- Schedule and conduct study visits, including protocol-specific assessments such as vital signs, specimen collection, medication/IP dispensing, and questionnaire administration.
- Monitor participants throughout the study to confirm adherence to protocol requirements and identify safety concerns.
Data & Source Documentation
- Complete and maintain source documentation and case report forms (CRFs/eCRFs) in CRIO and sponsor EDC systems (e.g., REDCap, Medidata) in real time and in accordance with ALCOA-C principles.
- Perform self-review of source-to-EDC data entry and respond promptly to sponsor/CRA data queries.
- Maintain accurate drug/IP dispensation and accountability logs for assigned protocols.
- Maintain accurate storage of IP logs.
- Prepare visit-level documentation for monitoring visits in coordination with the study team.
Safety & Regulatory Compliance
- Identify, document, and report adverse events (AEs) and serious adverse events (SAEs) to the PI and sponsor per protocol and regulatory timelines.
- Adhere to ICH-GCP, FDA regulations (21 CFR Parts 50, 56, 312), IRB determinations, and Urology Associates SOPs in all study-related activities.
- Maintain current human-subjects protection (CITI) and Good Clinical Practice (GCP) training per department requirements.
- Escalate protocol deviations, safety signals, or compliance concerns to the Clinical Research Department Manager and PI without delay.
Site Operations Support
- Maintain adequate study-specific supplies and equipment in working order for assigned protocols.
- Collaborate with the Regulatory & Study Start-Up Coordinator during site activation to support feasibility, training, and readiness activities as needed.
- Contribute participant recruitment ideas and support enrollment strategy for assigned protocols.
- Participate in department meetings, training sessions, and continuous process improvement initiatives.
QUALIFICATIONS
Education
- Bachelor's degree in a health science, biology, nursing, or related field — preferred, not required.
- Equivalent combination of clinical education (RN, LPN, and Medical Assistant) and relevant experience will be considered in lieu of a degree. Equivalent clinical education would be viewed as a plus.
Experience
- 1+ year of clinical research coordination experience — preferred.
- Candidates without direct clinical research experience but with a clinical background (RN, LPN, MA, phlebotomy, CNA) and strong interpersonal skills are encouraged to apply.
Certifications & Training
- MedTrainer – required as part of your onboarding with Urology Associates
- CITI Program human-subjects protection training — required within 30 days of hire (site-provided).
- GCP/ICH E6 training — required within 90 days of hire (site-provided).
- Current CPR/BLS certification — preferred.
Preferred, Not Required
- Registered Nurse (RN) licensure
- Prior experience as a Medical Assistant, LPN, or phlebotomist
- CCRC (ACRP) or CCRP (SOCRA) clinical research certification
- Experience with CRIO, REDCap, or Medidata EDC platforms
- Prior experience in urology or a related specialty
Skills & Competencies
- Excellent interpersonal, written, and verbal communication skills; comfort engaging directly with patients.
- Strong attention to detail and analytical mindset for protocol-specific assessments and data accuracy.
- Sound organizational skills with the ability to manage multiple participants and visit schedules concurrently.
- Working proficiency in Microsoft Office and willingness to learn EDC/eSource platforms within 30 days of hire.
- Commitment to continual self-education and adherence to ethical research standards.
PHYSICAL REQUIREMENTS & WORKING CONDITIONS
- Ability to stand and move throughout clinic areas for extended periods during study visit days.
- Ability to lift and carry study supplies and equipment up to 20 lbs.
- Comfort with clinical procedures including venipuncture/specimen handling as required by protocol (or willingness to be trained).
- On-site position at Urology Associates, P.C. clinical locations; not eligible for remote work.
GROWTH PATH
This role sits at the foundation of the Clinical Research Department's career ladder. Demonstrated competency, certification progress, and protocol ownership create a pathway toward the Senior Clinical Research Coordinator role, which carries expanded protocol leadership and mentorship responsibilities.
Summary
UA offers an excellent benefits package!
- Company Paid Holidays
- Vacation and Sick Time, Plus 2 Personal Days per Year
- Medical and Vision Insurance
- Dental Insurance
- Basic Life and AD&D Insurance (Company Paid!)
- Optional Short-Term Disability
- Optional Additional Life Insurance for Employee and/or Family Members
- Health Savings Account options
- Profit Sharing (Company Paid!)
- Employer Match for Retiring Savings!