Full Job Description Job Title :

Clinical Research Coordinator II FSLA Classification :

Non-Exempt Reports to :

CRC 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 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:

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Oncology Clinical Research Coordinator II