Clinical Research Coordinator II

Tekton Research Inc•San Antonio, TX

3h•Onsite

About The Position

The Clinical Research Coordinator (CRC II) manages the daily operations of assigned clinical trials. It is the responsibility of the CRC II to communicate with the investigator, sponsor and study participants all necessary information of the study. It is the responsibility of the CRC II to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner.

Requirements

Ability to work independently and as a member of a team
GED or HS Diploma required
2 - 5 years clinical research experience required

Nice To Haves

Experience leading 3-5 studies preferred
Some College preferred

Responsibilities

Inform study participants or caregivers about study procedures and outcomes to be expected
Train study team members and 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 study participants visit is occurring and while the study participant is on site for optimal accuracy of data collection
Have all source documentation completed, entered into EDC within 48 hours of study participants visit
Inventory lab and study supplies. Order supplies or delegate to Research Assistant to order needed supplies
Attend investigator meetings with principle investigator: asks questions and collects pertinent study information while at investigator meeting
Attend site initiation visits from various drug sponsors and conduct site initiation tours
Confer with business/recruitment department to determine the best recruitment practices for studies
Maintain required records of study activity including case report forms, drug dispensation records
Communicate with laboratories or investigators regarding laboratory findings
Order drugs or devices necessary for study completion
Direct the requisition, collection, labeling, storage, or shipment of specimens
Perform specific protocol procedures such as interviewing study participants, 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
Maintain contact with sponsors to schedule and coordinate site visits/monitoring visits
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 study participants in appropriate medication log
Initiate and maintain accurate master logs for each study. (ICF, study participants ID, and enrollment)
Prepare for or 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 log
Maintain accurate temperature logs daily as needed
Prepare study participants source documents prior to study participants visit
Maintain training logs on all up-to-date studies
Maintain and update study delegation logs
Maintains all safety reports for all studies. Make sure that PI is aware of safety reports to be completed and signs off in a timely manner
Other duties as assigned