Coordinator of Clinical Trials - Business Office - Kinston, NC

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946483

Vidant Medical Group

Full-Time

Regular

Vidant Health

About Vidant Medical Group

Vidant Medical Group is a reputable and established multi-specialty physician group that provides superior care for the health and wellness needs of eastern North Carolina's patients. With 500 primary and specialty care providers in 90 locations, quality health care is never far from home.

Position Summary

The IRE and or Regulatory Coordinator is responsible for reviewing and opening all new trials deemed by the Medical Director to benefit our patient population and not compete with ongoing studies.

The !RB/Regulatory Coordinator will be familiar with all clinical trials open at MLSCC and is the main contact for all parties involved in regulatory, budgeting, and contracting including the cooperative group studies, pharmaceutical companies, or other parties and institutions contracting with MLSCC to conduct clinical trials.

Accuracy is extremely important in this position for coordinating and documenting the overall activities listed above. Failure to do so can lead to patient harm, study suspension, or closure and audit deficits.

Responsibilities

  • Coordinates and completes IRE/Regulatory requirements for new and existing protocols
  • Assists in screening new patients for potential trials opportunities
  • Identifies and reviews new protocols, with assistance of the Medical Director, in a timely manner
  • Opens new protocols to include all !RB/Regulatory requirements for each individual protocol
  • Maintains all regulatory requirements for existing protocols and keeps clinical trials staff aware of all research changes for each protocol
  • Collects, organizes, enters, and analyzes protocol data on a regular basis for in-house review and review by governing study groups
  • Maintains a database to record all active protocols and patients accrued to each protocol
  • Collects inpatient and outpatient data as needed for source documentation
  • Participates in problem resolution activities
  • Coordinates with tumor registry for an exchange of data
  • Responsible for maintaining and revising informed consents
  • Maintains safety reports per individual protocol requirements
  • Responsible for submitting timely CRFs, queries, etc. on all study patients who are in follow-up status
  • Responsible for conducting the monthly clinical trials meeting
  • Responsible for financial accountability of the clinical trials department with support from Beaufort Hospital Accounting, and assistance of the Practice Manager
  • Maintains accurate financial records/database of each study being conducted available treatment protocols. Serves as a liaison with national study groups, Marion L. Shepard Cancer Center, pharmaceutical companies, and other Cancer Centers for multi-site clinical/trials/research
  • Serves as a resource to Marion L. Shepard Cancer Center and other Cancer Centers or referring physicians about the availability of specific protocols
  • Coordinates with other protocol nurses, physicians, and staff to prepare for protocol
  • review by the pharmaceutical companies and study groups
  • Advocates for clinical trials by participating in community outreach efforts to provide general clinical trials education when opportunities arise
  • Advocates for the safety  and  care of clinical trial patients as well as for the promotion and integrity of the clinical trial
  • Maintains Beaufort Hospitals Federal wide Assurance (FWA) and ensures compliance with its terms, as well as Beaufort Hospitals/Marion L. Shepard Cancer Centers policies and procedures, federal regulations, and state and local laws  relative

 

  • Ethical Professionalism
    • Promotes ongoing compliance with key ethical concepts by the research team, including
    • informed consent, documentation, respect for persons, beneficence, and justice

 

  • Leadership and Professionalism
    • Demonstrates strong leadership and interpersonal skills
    • Demonstrates effective decision-making/problems solving skills
    • Demonstrates teaching, learning, and counseling skills
    • Demonstrates effective communication, both verbal and written
    • Verifies posted work schedule, work schedule hours, and is punctual to work
    • Follows hospital procedure for notification of absence
    • Adheres to MLSCC dress code
    • Reads and signs new policies, procedures, and memos
    • Attends scheduled clinic staff meetings and reads and signs minutes whenever he/she cannot attend
    • Presents professional image for students and staff

Minimum Requirements

  • Must maintain a valid North Carolina drivers license or be licensed in the state of residence and maintain the VH required insurance limits.

Preferred Requirements

  • Associate Degree
  • Research trial coordinator experience or educational background stongly preferred

General Statement

It is the goal of Vidant Health and its entities to employ the most qualified individual who best matches the requirements for the vacant position.

Offers of employment are subject to successful completion of all pre-employment screenings, which may include an occupational health screening, criminal record check, education, reference, and licensure verification.

We value diversity and are proud to be an equal opportunity employer.   Decisions of employment are made based on business needs, job requirements and applicant’s qualifications without regard to race, color, religion, gender, national origin, disability status, protected veteran status, genetic information and testing, family and medical leave, sexual orientation, gender identity or expression or any other status protected by law. We prohibit retaliation against individuals who bring forth any complaint, orally or in writing, to the employer, or against any individuals who assist or participate in the investigation of any complaint.

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