PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please apply.

Kelly® Science & Clinical is seeking a Clinical Research Coordinator I – Unblinded for a temporary position (with potential to extend/convert) at a leading client in Fort Collins, CO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay Rate: 
$20.00+/Hour (commensurate with experience)

Overview:
The Unblinded Clinical Research Coordinator supports the daily operations of assigned clinical trials. It is the responsibility of the Unblinded CRC 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. When working in an Unblinded capacity, the Unblinded CRC’s primary role is managing the Investigational Product (IP) for clinical research trials. This includes, but is not limited to, the receipt, storage, dispensing, destruction, return and administration of IP. The Unblinded CRC is responsible for maintaining the blind of the study for trials required to have blinded and unblinded staff roles. The Unblinded CRC must be the expert on all aspects of IP management for each study they are responsible for. The Unblinded CRC will quickly problem solve issues that may arise with IP management, including reporting dosing discrepancies, ordering issues, and storage excursions. Reports to: Site Manager/Director.

Schedule:
•    Monday – Friday, 1st/Day: 8:00 AM – 5:00 PM (longer hours/weekend OT as needed)

Responsibilities:
CRC Duties:
•    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.
Unblinded Duties:
•    Prepares the site for conduct of the study – assures the site is prepared to conduct study:
o    May include coordinating of clinical research trial(s) that do not have a blind component as required.
o    Attend Investigator’s meeting and Site Initiation Visits.
o    Train backup Unblinded/Pharmacy Team members as needed.
o    Obtain all training on IP and provide information for others to obtain training as needed.
o    Ensure the site has obtained all required IP documents and equipment to conduct study.
o    Communicate with the sponsor in a timely manner regarding all aspects of IP management.
o    Prepare source documents for IP preparation and administration, if necessary.
•    Manages all aspects of Investigational Product:
o    Inventory investigational product upon receipt.
o    Maintains unblinded pharmacy binder and all essential documents required in binder.
o    Maintains accurate IP accountability, including upkeep of any IP logs required by Sponsors.
o    Dispenses and prepares investigational products per IP manual.
o    Administers IP as per the IP manual.
o    Communicates with unblinded monitor and performs unblinded monitor visits.
o    Ensures temperatures are within range for all IP storage equipment.

Qualifications:
Required Skills/Abilities:
•    6 months – 2 years clinical research experience preferred.
•    Ability to work independently and as a member of a team.
•    GED or HS Diploma required (Some College preferred).
•    Ability to work independently and as a member of a team.
•    Local travel required in multi-site locations.
Education & Experience:
•    College or medical certification required.
•    Pharmacy technician experience preferred.
Physical Requirements:
•    Prolonged periods of sitting at a desk and working on a computer.
•    Must be able to lift up to 15 pounds.
•    Must be able to travel between sites.

What Happens Next:
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

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