Clinical Research Coordinator I
Tekton Research Inc•Marlboro Township, NJ
•Onsite
About The Position
The Clinical Research Coordinator (CRC) I supports the daily operations of assigned clinical trials. It is the responsibility of the CRC I to communicate with CRC II or CRC III, site manager and study participants regarding necessary information of the study. Adherence to site SOPs is required.
Requirements
- Ability to work independently and as a member of a team
- GED or HS Diploma required
- Ability to work independently and as a member of a team
Nice To Haves
- 6 months - 2 years clinical research experience preferred
- Some College preferred
Responsibilities
- Inform patients or caregivers about study procedures and outcomes to be expected
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
- Have all source documentation filled out and completed while the patient visit is occurring and while the patient is on site for optimal accuracy of data collection
- Have all source documentation completed, entered into EDC within 48 hours of patient visit
- Inventory lab and study supplies. Notify manager when supplies need to be ordered
- Maintain required records of study activity including case report forms, drug dispensation records
- Perform specific protocol procedures such as interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to sponsors
- Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor
- Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as necessary
- Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost or damaged. Logging dispensed medication to subjects in appropriate medication log
- Initiate and maintain accurate master logs for each study. (ICF, patient ID, and enrollment).
- Participate in quality assurance audits
- Label and organize space for drug. All drug received should be put in drug cabinets immediately once drug arrives to site after being checked in and logged into the drug logs
- Maintain accurate temperature logs daily as needed
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
