Clinical Research Coordinator II

Job Title: Clinical Research Coordinator II

FSLA Classification: Non-Exempt

Reports to: Site Operations Manager

Job Summary/ Objective:

The Clinical Research Coordinator II is responsible for supporting the management and oversight of clinical trials. This role involves working closely with a team to ensure the smooth execution of research studies under the guidance of the Site Operations Manager.

Essential Functions:

Overseeing Clinical Trials:

• Ensure trouble-free running of clinical trials.
• Monitor study participants’ health throughout the trial.
• Compile reports summarizing the success or failure of drugs, technologies, or medical procedures.
• Oversee 3-4 trials

Data Collection and Analysis:

• Collect data obtained from research.
• Analyze research data.
• Participant Interaction:
• Communicate with study participants regarding study objectives.
• Administer questionnaires.
• Monitor participant adherence to study rules.

Collaboration and Compliance:

• Liaise with laboratories
• Monitor study compliance with protocols and ethical standards.
• Ensure adherence to regulatory requirements.

Record Keeping:

• Maintain research records, including case report forms and drug dispensation records.
• Direct specimen collection, labeling, storage, and transport.

Logistics and Supplies:

• Ensure all necessary equipment and supplies are in stock and functional.

Education/Experience/Skills:

Education: Bachelor's degree preferred in a health-related field

Experience: 2 years of experience in Clinical Research

Skills:

Regulatory

• Filing and accessing documents, Study Submission Assistant, Conduct Close out Visits

Finance

• Stipend payments

Subject Interaction

• Recruit, interview, screen, enroll, and randomize subjects
• Obtain Informed Consent
• Collect medical history
• Conduct study visits

Administrative

• Source documentation
• EDC
• Query resolution
• AE/SAE documentation and reporting
• Address protocol violations and deviations
• Order supplies

Clinical Skills

• Phlebotomy
• Vital Signs
• ECG

Working Conditions/ Physical Demands:
Standard operating hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. May be required to complete job-related tasks outside of that time frame in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare, and communicate appropriate reports.

Travel required: as needed (travel to IM’s may be required)

Disclaimer

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.