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:
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

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)