Lead Clinical Research Coordinator

Charter Research, LLC; Orlando (FL); On-site; USD 65,000 - 90,000; Full time

Job summary

Charter Research, LLC is seeking a Lead Clinical Research Coordinator to oversee daily trial operations and guide patients through the clinical trial process. You will ensure protocol adherence, coordinate visits, collect data, and maintain source documentation in line with ALCOA-C and HIPAA requirements.

The role requires Spanish fluency, 2–4 years of CRC experience or equivalent, and strong organizational and communication skills.

Qualifications

• Fluency in Spanish is required.
• 2–4 years of relevant experience, or 2+ years as a Clinical Research Coordinator.
• Knowledge of medical terminology is required.
• CCRC or equivalent professional certification preferred.

Responsibilities

• Oversee day-to-day operations of clinical trials and guide patients through the trial process.
• Adhere to study protocols and Good Clinical Practice (GCP).
• Educate patients and families about trial details.
• Assess eligibility and oversee patient enrollment with informed consent.
• Coordinate patient visits, collect data and specimens per protocol.
• Communicate trial issues to Sponsor/CRO, PI and Clinic Manager.
• Maintain ALCOA-C compliant source documentation and audit readiness.
• Assist in sponsor monitoring and data maintenance processes.
• Provide training to new team members and seek process improvements.

Skills

Interpersonal skills

Customer service

Organizational skills

Attention to detail

Verbal communication

Written communication

Multitasking

Adaptability

Team collaboration

Problem solving

Public speaking

HIPAA compliance

Education

CCRC or equivalent professional certification

Job description

POSITION OVERVIEW

The Lead Clinical Research Coordinator is responsible for overseeing the day-to-day operations of clinical trials. The Lead Clinical Research Coordinator 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.
• Provides training to new team members and reviews their work for accuracy.
• Identifies and communicates opportunities to improve existing processes.
• Assists in the coordination of team meetings and presents information and updates as needed.
• Communicates complex clinical trial information in a clear manner and applies tact and diplomacy to deliver sensitive information.
• May perform some managerial duties as directed and under the supervision of a manager or director.
• Maintain a “One Team” approach to trial success. To maintain healthy patient flow and ensure the success of all trials, team members may be temporarily reassigned to patient engagement or clinic responsibilities, as appropriate. This flexibility is essential to meeting our contractual obligations and ensuring a seamless experience for all trial participants.
• Perform other duties as assigned.

KNOWLEDGE, SKILLS, AND ABILITIES

• Excellent interpersonal and customer service skills.
• Exceptional organizational skills and attention to detail.
• Strong verbal and written communication skills.
• Ability to handle multiple tasks simultaneously and adapt to changes in responsibilities and workloads.
• Collaborates with team effectively, building and nurturing strong relationships.
• Recognizes and solves problems to perform work independently.
• Comfortable speaking and presenting professionally to internal and external groups.
• Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters, and other sensitive information.

QUALIFICATIONS

Language

Fluency in Spanish is required.

Education

• CCRC (or equivalent) professional certification preferred.

Experience

• Typically, 2-4 years relevant experience, or 2+ years of experience as a Clinical Research Coordinator.
• Knowledge of medical terminology 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.