Clinical Research Coordinator II

at  Helios Clinical Research

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.

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

o Ensure adherence to regulatory requirements.

• Record Keeping

• Overseeing Clinical Trials:
  o Ensure trouble-free running of clinical trials.
  o Monitor study participants’ health throughout the trial.
  o Compile reports summarizing the success or failure of drugs, technologies, or medical procedures.

o Oversee 3-4 trials

• Data Collection and Analysis:

o Collect data obtained from research.

o Analyze research data.

• Participant Interaction:

o Communicate with study participants regarding study objectives.
o Administer questionnaires.

o Monitor participant adherence to study rules.

• Collaboration and Compliance:

o Liaise with laboratories
o Monitor study compliance with protocols and ethical standards.

o Ensure adherence to regulatory requirements.

• Record Keeping:

o Maintain research records, including case report forms and drug dispensation records.

o Direct specimen collection, labeling, storage, and transport.

• Logistics and Supplies:

o Ensure all necessary equipment and supplies are in stock and functional.
Education/Experience/Skills:
Education: Bachelor’s degree preferred in health-related field
Experience: 2 years experience in Clinical Research

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

• Regulatory

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

• Finance

o Stipend payments

• Subject Interaction

o Recruit, interview, screen, enroll, and randomize subjects
o Obtain Informed Consent
o Collect medical history

o Conduct study visits

• Administrative

o Source documentation
o EDC
o Query resolution
o AE/SAE documentation and reporting
o Address protocol violations and deviations

o Order supplies

• Clinical Skills

o Phlebotomy
o Vital Signs
o ECG