Clinical Research Nurse Coordinator

Quality Assurance Nashville, Tennessee


Description

Clinical Research Nurse Coordinator job, Full-Time, Quality Assurance

Nashville General Hospital is hiring a Clinical Research Nurse Coordinator for Quality Assurance as a full time job in Nashville, Tennessee.
 

Shift: Day Shift

The Clinical Research Nurse Coordinator (CRNC) promotes good clinical practice (GCP) in the conduct of clinical trials by possessing in-depth knowledge of federal regulations and guiding documents for the conduct of clinical trials and human participant protection. In addition, the CRNC assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records and maintains data and source documentation. The CRNC performs all the duties and responsibilities associated with high-level, professional nursing practice including autonomous decision making based on predetermined protocol guidelines, nursing assessment and oncology knowledge.


  

Clinical Research Nurse Coordinator Roles and Responsibilities:  

  • Coordinates patient enrollment in clinical trial by following randomization procedures as per protocol, scheduling patient office visits, required screening assessments, ensuring appropriate specimen collection, batching and shipping per protocol and assessing participant compliance with the test article and follow-up visits.
  • Manages clinical trials patient by scheduling all protocol required tests, physician and nurse assessment visits, monitoring patients’ response to protocol treatment, accompanying the physician for all protocol required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health System IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision.
  • Ensures patient safety with ongoing patient education about cancer treatment and disease process. Performs skilled nursing assessment and promptly reports all findings to investigator and sponsor. Recognizes laboratory values and assessment findings which are outside of normal limits.
  • Documents and Maintains all Study-Related Procedures, Processes and Events by obtaining and reviewing original source documents (e.g., office notes, scans, tests, procedure results), abstracting data to study forms and flowsheets, recording accurate and timely data into electronic or hard copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to be used in protocol implementation and resolving data queries- amending case report forms as appropriate.
  • Maintains Investigational Agent Accountability with proper utilization of drug logs and patient diaries; ensuring protocol guidelines are adhered to by all pharmacy staff.
  • Protects Participant Confidentiality by adhering to HIPAA regulations, protecting patient privacy at all times, securing safe storage of study-related documents, assuring appropriate disposal of PHI, securely storing all archived files.
  • Communicates effectively with Patients, Research Team, IRB, Sponsor, and Clinical Trials Manager by providing protocol education to ancillary staff. Establishing a contact mechanism for participants regarding follow-up visits, new information and encouraging study participants to report study-related events to the research team immediately. Effective communication with investigator and sponsor representative to ensure protocol compliance. Punctually submitting reports, suggestions and concerns to Manager.
  • Participates in monitoring visits and audits by collecting source documents for sponsor/audit review, meeting with monitors/auditors during routine visits to discuss case report form completion, query resolution and other protocol-related issues, preparing for and participating in FDA inspections as needed.
  • Participates in the orientation and training of new research staff/ancillary staff involved in administering protocol treatments. Supervise Clinical Research Associate(s).
  • Implements quality controls and assurance measures by monitoring compliance with study procedures and GCP standards, conducting quality assurance audits as requested, working with internal and external quality assurance teams.
  • Maintains professional and technical knowledge by attending relevant meetings at the discretion of the manager, presenting professional education to colleagues, performing self-directed study to maintain certification, reviewing professional publications and participating in professional societies. Completes all required IT training to access to various Electronic Data Capture systems and Electronic Medical Records. Proficient with basic office software such as Microsoft Office.


Required Skills and Qualifications:
  

  • Education must be sufficient to meet the standards for achievement of the below indicated license and/or certification as required by the issuing authority.
  • Valid Tennessee RN licensure. Research or specialty certification preferred e.g. Oncology Certified Nurse (OCN), Society of Clinical Research Associates (SOCRA), or Association of Clinical Research Professionals (ACRP).
  • Two (2) years of experience in clinical trials.
  • Excellent written and oral communication skills, project management skills.
  • Good Interpersonal and leadership skills.
  • Excellent computer skills.

About Nashville General Hospital  

Nashville General Hospital (NGH) is Nashville’s original community- based hospital. Joint Commission accredited, NGH readily accommodates a wide range of needs from emergency services and acute care to ancillary and ambulatory services. NGH continues to maintain its strong commitment to the healthcare needs of Nashville and Davidson County underserved, while also providing care to all segments of the community.

  

Our benefits include:  

  • Medical, Dental, and Vision Insurance within first 31 days of employment
  • Programs to reduce share of deductible and total out-of-pocket expenses
  • Metro Health Incentive Program - Access to high quality healthcare without incurring out-of-pocket expenses
  • Short and Long-Term Disability - up to 60% of eligible weekly pay
  • Life Insurance - Metro provides you with basic life and AD&D coverage equal to $50,000 ($32,500 if you are age 65 or older), at no cost to you.
  • Retirement Plan - eligible up to IRS max limits and includes company contribution
  • Shift and Weekend Differential Pay Offered on Nights and Weekends
  • Tuition Reimbursement for employee and dependents
  • 12 paid holidays - any holiday worked is another holiday banked
  • Flexible Spending Accounts
  • Free Parking for all employees

   

Join our team at Nashville General Hospital. Apply today!  

We are an E-Verify employer.

For more information, please click on the following links:
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