Clinical Research Coordinator
The Villages
COMPANY 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
Language
- Must be fluent in Spanish, both spoken and written. (For Winter Park location only.)
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.
