Senior Clinical Research Coordinator

Green Key Resources; Jackson (TN); On-site; USD 50,000 - 60,000; Full time

Job summary

Green Key Resources seeks Clinical Research Coordinators to support trials at Lakeland, FL; Jackson, TN; and North Charleston, SC. This full-time, onsite role involves direct contact with study participants and collaboration with investigators, sponsors, monitors, and laboratories.

Ideal candidates have at least one year of clinical research experience; two or more years may qualify for the Clinical Research Coordinator II level.

Qualifications

• At least one year of clinical research or relevant clinical experience.
• Hands-on experience with patients or study participants.
• Experience with participant screening, informed consent, and visits.
• Familiarity with EDC systems and data queries.
• Ability to work full-time onsite at one of the listed locations.

Responsibilities

• Coordinate and oversee assigned clinical trials from start-up through closeout.
• Manage multiple studies and competing priorities in a busy site.
• Prepare for site initiation visits and regulatory filings.
• Recruit and enroll eligible participants and obtain informed consent.
• Ensure compliance with protocols, GCP, HIPAA, and FDA regulations.

Skills

Clinical coordination

Patient interaction

Regulatory knowledge

Data entry

Documentation

Education

Bachelor's degree in health-related field

Tools

Electronic data capture (EDC)

Microsoft Office

EMR systems

Job description

Clinical Research Coordinator II (FL, TN, or SC)

Locations

• Lakeland, FL
• Jackson, TN
• North Charleston, SC

Schedule: Full-time, onsite

Position Type: Direct Hire

Compensation

• Lakeland, FL: $66,000-68,000 annually (some flexibility for experience)
• Jackson, TN: $50,000-60,000 annually (some flexibility for experience)
• North Charleston, SC: $62,400-72,800 annually, with potential eligibility for a 5% site performance bonus (some flexibility for experience)

Position Overview

We are seeking Clinical Research Coordinators to support the management and execution of clinical trials at established research sites in Lakeland, Florida; Jackson, Tennessee; and North Charleston, South Carolina.

This is a full-time, onsite position involving direct interaction with study participants. The Clinical Research Coordinator will work closely with investigators, site leadership, sponsors, monitors, laboratories, and other members of the clinical research team to ensure assigned studies are conducted safely, efficiently, and in compliance with study protocols, Good Clinical Practice (GCP), ICH guidelines, HIPAA requirements, FDA regulations, and site procedures.

Candidates should have at least one year of clinical research or relevant clinical experience. Candidates with two or more years of hands-on, patient-facing clinical research experience may be considered for the Clinical Research Coordinator II level.

Key Responsibilities

Clinical Trial Coordination

• Coordinate and oversee assigned clinical trials from study start-up through closeout.
• Manage multiple studies and competing priorities in a busy clinical research environment.
• Complete study start-up activities, including required training, document collection, regulatory filing, and preparation for site initiation visits.
• Participate in site initiation visits, investigator meetings, monitoring visits, and closeout visits.
• Ensure trials are conducted according to the study protocol, regulatory requirements, ethical standards, and internal procedures.
• Identify study-related concerns and work with the research team to implement timely solutions.
• Ensure study-related reports and participant results are reviewed by the investigator within required timelines.

Participant Recruitment and Study Visits

• Recruit, interview, screen, enroll, and randomize eligible study participants.
• Explain study objectives, requirements, risks, benefits, and procedures to potential participants.
• Obtain and properly document informed consent.
• Collect and document medical histories and relevant participant information.
• Schedule and conduct study visits according to protocol.
• Administer questionnaires, assessments, and other protocol-required procedures.
• Conduct follow-up visits and provide appointment reminders.
• Monitor participant safety, compliance, and adherence throughout the study.

Clinical Procedures

• Obtain and document vital signs.
• Perform ECGs.
• Perform phlebotomy and blood specimen collection.
• Process, centrifuge, label, store, package, and ship laboratory specimens.
• Maintain specimen accountability and coordinate courier pickup.
• Perform additional protocol-required clinical procedures within the coordinator's qualifications and training.

Documentation and Data Management

• Create and maintain accurate source documentation and study records.
• Review data for accuracy, completeness, and consistency.
• Respond to and resolve data queries within required timelines.
• Maintain case report forms, participant records, study logs, regulatory files, and investigational product or drug accountability records.
• Request and track medical records.
• Build and update source documents as needed.
• Follow ALCOA/ALCOAC documentation principles.

Safety and Regulatory Compliance

• Document and report adverse events and serious adverse events.
• Identify, document, and address protocol deviations.
• Submit required safety, deviation, and regulatory reports to sponsors, investigators, and institutional review boards.
• Report noncompliance or study concerns to appropriate site leadership.
• Assist with regulatory submissions, filing, and study document maintenance.
• Protect participant confidentiality and handle sensitive information in accordance with HIPAA requirements.

Site Operations

• Maintain and update regulatory binders, study files, participant charts, and study logs.
• Order and maintain study-specific supplies.
• Ensure clinical equipment and supplies are available, functional, and properly stored.
• Assist with participant stipend payments and related documentation.
• Set up, maintain, and support study-related technology and systems.
• Maintain professional and effective communication with participants, investigators, sponsors, monitors, laboratories, and internal team members.
• Perform other study-related responsibilities as assigned.

Minimum Qualifications

• At least one year of clinical research or relevant clinical experience.
• Hands-on experience working directly with patients or study participants.
• Experience with participant screening, informed consent, study visits, source documentation, and data entry.
• Familiarity with electronic data capture systems and query resolution.
• Ability to work full-time and onsite at one of the listed locations.
• Strong organizational skills and attention to detail.
• Strong written, verbal, interpersonal, and listening skills.
• Ability to manage multiple responsibilities and adjust to changing priorities.
• Ability to work independently while collaborating effectively with a research team.
• Proficiency with Microsoft Office, email, electronic health records, and web-based clinical research systems.
• Ability to maintain confidentiality and handle sensitive information professionally.
• High level of integrity, dependability, professionalism, and work ethic.

Preferred Qualifications

The following qualifications are preferred but are not required for every location:

• Two or more years of clinical research experience.
• Approximately three years of clinical research experience.
• Previous oncology clinical research experience.
• Experience overseeing multiple clinical trials.
• Experience with study start-up, patient enrollment, active study conduct, and study closeout.
• Experience preparing for or participating in site initiation visits, monitoring visits, investigator meetings, and closeout visits.
• Experience with regulatory submissions and study document filing.
• Experience documenting and reporting adverse events, serious adverse events, and protocol deviations.
• Proficiency with phlebotomy, vital signs, ECGs, and specimen processing.
• Bachelor's degree in a health-related field.
• Associate's degree, Medical Assistant diploma, LPN/LVN license, EMT credential, or other relevant healthcare education.
• Bilingual English and Spanish proficiency.