What are the responsibilities and job description for the Clinical Research Coordinator position at Helios Clinical Research?
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
Collect data obtained from research.
Analyze research data.
Communicate with study participants regarding study objectives.
Administer questionnaires.
Monitor participant adherence to study rules.
Liaise with laboratories
Monitor study compliance with protocols and ethical standards.
Ensure adherence to regulatory requirements.
Maintain research records, including case report forms and drug dispensation records.
Direct specimen collection, labeling, storage, and transport.
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
Filing and accessing documents, Study Submission Assistant
Stipend payments
Recruit, interview, screen, enroll, and randomize subjects
Obtain Informed Consent
Collect medical history
Conduct study visits
Source documentation
Query resolution
AE / SAE documentation and reporting
Address protocol deviations
Order supplies
Phlebotomy
Vital Signs
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)