About This Role
This onsite role involves ensuring the safety of volunteers, promoting Accellacare's mission, and striving to meet and exceed study priorities. The Clinical Research Coordinator 1 is responsible for recruiting and promoting services to suitable participants and sponsor representatives, as well as performing tasks required to coordinate and complete studies according to protocol.
Responsibilities
- Perform technical and clinical requirements of study protocols, including venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holter 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
- Attend 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
- Obtain knowledge about the study drugs with an emphasis on injection or intravenous infusion medications
- Monitor for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions
- Maintain 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
- Document laboratory data and adverse reactions, and immediately notify investigators, sponsors, and the Institutional Review Board, if indicated, of any unexpected or serious events
- Assist other staff members as determined by the needs and priorities of the research organization and as time and abilities permit
- Actively recruit and effectively sell services to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts
- Proactively promote the site with monitors and in-house contacts for future trials
- Respond to queries in a timely manner, prompt data entry, and work with the monitor during on-site visits
- Prepare study documentation in the event of a sponsor or FDA audit and assist the auditor for the duration of the audit
- Order clinical supplies, as well as order, store, and monitor protocol-specific rescue drugs and maintain scheduled assessment of the code/crash cart and AED, including maintaining proper documentation for both
- Monitor and maintain refrigerators, freezer units, and investigational product storage temperatures for safety and stability
- Obtain and maintain knowledge regarding temperature monitoring devices and procedures for lab specimens and investigational products and provide detailed information to all staff and sponsors regarding how temperatures are monitored and maintained
