Clinical Research Coordinator

Charter Research, LLC; The Villages (FL); On-site; USD 55,000 - 75,000; Full time

Job summary

Charter Research, LLC in The Villages, FL, is seeking a Clinical Research Coordinator to oversee the day-to-day operations of clinical trials, guiding patients through the trial process and ensuring source data integrity.

You will work with Principal Investigators, educate participants, screen eligibility, coordinate visits and specimens, and support sponsor communications while maintaining HIPAA confidentiality and ALCOA-C documentation.

Qualifications

• Bachelor’s degree strongly preferred in psychology, biology, health sciences, or related field.
• CCRC certification preferred.
• LPN/RN licensure or medical certification is a plus.
• 1–3 years of related experience required.

Responsibilities

• Oversee day-to-day operations of clinical trials.
• Adhere to study protocols and GCP requirements.
• Educate patients and families about trials and participate in consent processes.
• Assess eligibility and oversee patient enrollment.
• Coordinate patient visits, collect data, and manage specimens.
• Communicate with sponsor/CRO, PI, and clinic staff.
• Maintain ALCOA-C source documentation and audit readiness.
• Support sponsor monitoring and data maintenance.
• Respond to monitor and sponsor queries in a timely manner.
• Track enrollment and communication with participants throughout participation.
• Prepare for quality assurance audits as needed.

Skills

Interpersonal skills

Customer service

Organizational skills

Communication skills

Teamwork

Multitasking

HIPAA confidentiality

Phlebotomy

Education

Bachelor’s degree in psychology/biology/health sciences or related field

CCRC certification

LPN/RN licensure or medical certification

Job description

Charter Research is a highly experienced and quickly growing clinical research company, based in The Villages and Orlando, FL that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is locally owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in The Villages.

POSITION OVERVIEW

The Clinical Research Coordinator (CRC) is responsible for overseeing the day-to-day operations of clinical trials designed to test the safety and effectiveness of new drugs. The CRC plans and directs clinical research studies – working directly with patients to guide them successfully through the clinical trial process – and is responsible for managing clinical trial performance. Team Members in this role are expected to follow Good Clinical Practice (GCP) in the conduct of clinical investigations and to collect, record, and maintain source and sponsor documentation.

RESPONSIBILITIES

• Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator.
• Adhere strictly to the study protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and other requirements.
• Educate patients and their family members regarding the clinical trials process and the details of the specific study in which they’re participating.
• Assess eligibility of potential patients and oversee patient enrollment to ensure that informed consent is properly obtained and documented.
• Coordinate and conduct patient visits (drawing blood, collecting vital signs, performing ECGs, and processing specimens) and assure all procedures are conducted in compliance with the clinical trial protocol and Good Clinical Practice (GCP).
• Communicate clinical trial issues to Sponsor and/or Contract Research Organization (CRO), Principal Investigator, and Clinic Manager.
• Keep all source documentation up-to-date and in compliance with ALCOA-C standards.
• Communicate closely with the sponsor’s Clinical Research Associate (CRA) to facilitate the sponsor monitoring and data maintenance process.
• Complete all monitor and sponsor queries in a timely manner.
• Track enrollment status of patients and ensure timely communication with patients regarding their study participation.
• Prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.

KNOWLEDGE, SKILLS, AND ABILITIES

• Excellent interpersonal and customer service skills.
• Knowledge of medical terminology.
• Exceptional organizational skills and attention to detail.
• Strong verbal and written communication skills.
• Ability to work well both independently and as part of a team.
• Ability to handle multiple tasks simultaneously and adapt to changes in responsibilities and workloads.
• Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters, and other sensitive information.
• Phlebotomy skills are a plus.

QUALIFICATIONS

Education

• Bachelor’s degree strongly preferred – preferably in psychology, biology, health sciences, or a related field.
• Certified Clinical Research Coordinator (CCRC) certification preferred.
• Licensed Practical Nurse (LPN), Registered Nurse (RN), or other medical licensure or certification is a plus.

Experience

• 1-3 years of related experience required.

PHYSICAL REQUIREMENTS

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged periods of standing, bending, and reaching.
• Must be physically able to assist patients as needed, and able to lift up to 30 pounds at times.

Charter Research provides equal employment opportunity (EEO) 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.