Clinical Research Coordinator I

Title: CRC Level I (Clinical Research Coordinator)

Location: On-Site Rocky Mt NC

Summary: The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol.

Duties:

• Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator.
• Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures.
• Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications.
• Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions.
• Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication.
• Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events.
• Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit.
• Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts.
• Proactively promoting the site with monitors and in-house contacts for future trials.
• Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors.
• Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit.
• Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both.
• Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability.
• Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained.
• Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow.
• Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff.
• Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records.
• Supporting training and additional development of clinical skills for site staff as needed

To be successful, you will have:

• Bachelor's life science degree, or relevant industry-field experience
• 1 years' work experience in clinical research or pharmaceutical environment would be desirable
• High level of attention to detail
• Personable, able to build rapport with patients with ease
• Motivated about a career in clinical research
• Excellent planner, organized approach to work