Clinical Research Coordinator I

Job Title: Clinical Research Coordinator I

FSLA Classification: Non-Exempt

Reports to: Site Operations Manager

Job Summary/ Objective:

The Clinical Research Coordinator I 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 1-2 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 health-related field

Experience: 1 year experience in Clinical Research

Skills: (please refer to the Helios Upskilling Guide for the complete list of all skills required for this role)

• Regulatory
  • Filing and accessing documents, Study Submission Assistant
• 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 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)