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Clinical Operations Supervisor
2 months ago
Company Background
Charter Research is a rapidly expanding clinical research organization dedicated to advancing medical science. We pride ourselves on delivering outstanding patient experiences and implementing effective recruitment strategies for our sponsors. Our commitment to teamwork is at the core of our operations, and we are looking for a valuable addition to our Orlando team.
Position Summary
The Clinical Operations Supervisor will manage the daily functions of a clinical research facility. This role involves providing guidance and support to the clinical research personnel to ensure the collection of high-quality data, exceptional service to participants, and adequate patient visit volumes to foster the growth and success of the clinical research team. The ideal candidate will cultivate and maintain constructive working relationships with all Charter Research team members, patients, caregivers, sponsors, and representatives from Clinical Research Organizations (CROs) and vendors.
Key Responsibilities
- Ensure compliance with International Council on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and Charter Research Standard Operating Procedures (SOPs).
- Thoroughly review and comprehend all clinical research studies conducted in the unit by engaging with protocols, attending meetings, and collaborating with Clinical Research Coordinators and the Principal Investigator.
- Lead the clinical team in grasping the details of all clinical trials, facilitating training sessions, and ensuring effective communication.
- Guarantee adherence to study protocols, including patient visit requirements, informed consent processes, and laboratory procedures.
- Educate team members and assist them in informing patients and their families about the clinical trials process and specific study details.
- Oversee patient enrollment, ensuring proper execution and documentation of the informed consent process.
- Facilitate eligibility confirmation for potential patients through chart reviews.
- Communicate any clinical trial issues to sponsors, CROs, the Principal Investigator, and the Clinic Manager.
- Ensure timely creation and updating of all necessary source documents to minimize data entry errors and maintain compliance with study protocol requirements.
- Maintain clinical source documentation in accordance with ALCOA-C standards.
- Collaborate closely with the sponsor's Clinical Research Associates (CRAs) to support monitoring and data maintenance.
- Professionally manage interactions with patients and caregivers who may experience frustration during the clinical research process.
- Ensure patient and caregiver safety by addressing any potentially harmful situations that may arise during study participation.
- Strive for excellence in clinical trial performance, focusing on both enrollment and data collection. Regularly assess systems and study performance to identify areas for improvement.
- Identify and address potential issues or inconsistencies as they arise.
- Maintain clear communication regarding clinical matters with the clinical team, sponsors, CROs, monitors, auditors, and vendors.
- Provide ongoing training and oversight for clinic team members.
- Ensure compliance with training and certification requirements for all clinical team members, including Clinical Research Coordinators (CRCs) and Research Assistants (RAs).
- Facilitate scheduling for clinic visits and resolve related issues promptly.
- Ensure timely completion of all monitor and sponsor queries.
- Track patient enrollment status and maintain timely communication with patients regarding their participation.
- Prepare for and/or participate in quality assurance audits conducted by sponsors or regulatory agencies.
- Foster and uphold the company's core values within the team.
- Develop and sustain positive working relationships with all Charter Research team members.
- Perform additional duties as assigned.
Supervisory Responsibilities
Carry out supervisory duties in accordance with the organization's policies and applicable laws, including interviewing, hiring, training employees, planning, assigning, and directing work, appraising performance, coaching, and resolving complaints.
Knowledge, Skills, and Abilities
- Strong work ethic and motivation to enhance clinical operations.
- Broad understanding of all aspects of clinical trial operations.
- Ability to lead and manage a team effectively.
- Excellent communication and interpersonal skills.
- Exceptional organizational and planning abilities with keen attention to detail.
- Capacity to handle multiple tasks and adapt to changing responsibilities.
- Familiarity with medical terminology.
- High degree of integrity and ability to maintain confidentiality in accordance with HIPAA guidelines.
Qualifications
Language
Fluency in both English and Spanish is required.
Education
Bachelor's degree preferred, ideally in psychology, biology, health sciences, or a related field. Certification as a Clinical Research Coordinator (CCRC) is advantageous. Medical licensure or certification, such as Licensed Practical Nurse (LPN) or Registered Nurse (RN), is a plus.
Experience
1-3 years of relevant clinical research experience is required.
Physical Requirements
- Ability to sit for extended periods while working on a computer.
- Capability to stand, bend, and reach for prolonged periods.
- Physical ability 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 without regard to 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 federal, state, and local laws.
