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 a health-related field
Experience: 2 years of experience in Clinical Research
Skills:
• 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
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