Clinical Operations Supervisor

2 weeks ago

Orlando, Florida, United States CHARTER RESEARCH Full time
Job Overview

Company Overview
Charter Research is a dynamic and rapidly expanding clinical research organization dedicated to the discovery of innovative therapies. We pride ourselves on delivering outstanding patient experiences and implementing effective recruitment strategies for our partners.

Position Summary
The Clinical Operations Supervisor is tasked with managing the daily functions of a clinical research facility. This role involves providing guidance and support to the clinical team to ensure the collection of high-quality data, exceptional service to participants, and optimal visit volumes to drive the success of the research unit. The ideal candidate will foster strong relationships with all team members, participants, caregivers, sponsors, and representatives from Clinical Research Organizations (CROs).

Key Responsibilities

  1. Ensure compliance with International Council on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and internal Standard Operating Procedures (SOPs).
  2. Thoroughly review and comprehend all clinical research protocols, participating in relevant meetings and collaborating with Clinical Research Coordinators and Principal Investigators.
  3. Lead the clinical team in understanding the trials conducted within the unit, facilitating training sessions and effective communication.
  4. Guarantee adherence to study protocols, including patient visit requirements, informed consent processes, and laboratory procedures.
  5. Educate team members and assist them in informing patients and their families about the clinical trial process and specific study details.
  6. Oversee patient enrollment, ensuring informed consent is properly obtained and documented.
  7. Facilitate eligibility confirmation for potential participants through chart reviews.
  8. Communicate any clinical trial issues to sponsors, CROs, Principal Investigators, and Clinic Managers.
  9. Ensure timely creation and updating of source documents to minimize data entry errors and maintain compliance with study protocols.
  10. Maintain up-to-date clinical source documentation in line with ALCOA-C standards.
  11. Collaborate closely with sponsor representatives and travel Clinical Research Associates (CRAs) to support monitoring and data management.
  12. Professionally manage interactions with patients and caregivers, particularly in challenging situations.
  13. Ensure participant safety by addressing any potentially harmful situations during their involvement in studies.
  14. Strive for excellence in clinical trial performance, continuously reviewing systems and identifying areas for improvement.
  15. Identify and address potential issues or inconsistencies proactively.
  16. Maintain clear communication regarding clinical matters with the team, sponsors, CROs, monitors, and auditors.
  17. Provide ongoing training and oversight for clinic staff.
  18. Ensure compliance with training and certification requirements for all clinical team members.
  19. Facilitate scheduling for clinic visits and resolve any related issues promptly.
  20. Ensure timely completion of all sponsor and monitor queries.
  21. Track patient enrollment status and maintain communication regarding study participation.
  22. Prepare for and participate in quality assurance audits conducted by sponsors or regulatory bodies.
  23. Uphold the company’s core values and ensure they are practiced by the team.
  24. Develop and maintain positive working relationships with all team members.
  25. Perform additional duties as required.

Supervisory Responsibilities
Manage supervisory responsibilities in accordance with organizational policies and applicable laws, including interviewing, hiring, training, assigning work, evaluating performance, and addressing employee concerns.

Knowledge, Skills, and Abilities

  1. Strong work ethic and motivation to enhance clinical operations.
  2. Broad understanding of clinical trial operations.
  3. Ability to lead and manage a team effectively.
  4. Excellent communication and interpersonal skills.
  5. Exceptional organizational skills and attention to detail.
  6. Adept at multitasking and adapting to changing responsibilities.
  7. Familiarity with medical terminology.
  8. High degree of integrity and ability to maintain confidentiality.

Qualifications
Language

  1. Fluency in English and Spanish is required.
Education
  1. Bachelor's degree in psychology, biology, health sciences, or a related field is preferred.
  2. Certification as a Clinical Research Coordinator (CCRC) is preferred.
  3. Licensure as a Practical Nurse (LPN), Registered Nurse (RN), or other medical certification is advantageous.
Experience
  1. 1-3 years of relevant experience in clinical research is required.

Physical Requirements

  1. Ability to sit for extended periods while working on a computer.
  2. Ability to stand, bend, and reach for prolonged periods.
  3. Physical capability to assist patients as needed, including lifting up to 30 pounds.

Charter Research is committed to providing equal employment opportunities to all employees and applicants, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable laws.

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