PMG Research of Raleigh, Raleigh North Carolina, is seeking an enthusiastic medical professional for an exciting research opportunity.
We are looking for a full-time nurse or experienced research coordinator to join our team.
PMG offers a progressive work environment with medical and dental insurance coverage, and a 401-K savings plan.
Please submit resume via email only to: [Click Here to Email Your Resumé]
Under the direction of a physician, the clinical research coordinator facilitates conducting clinical research trials.
The position is responsible for completing trial assignments in an autonomous, accurate, and timely manner. This position involves staff development and training responsibilities.
The Clinical Research Nurse Coordinator reports to the Manager of Clinical Operations.
NATURE OF WORK AND JOB SCALE:
- Promoting the mission of PMG to bring clinical research to as many lives as possible while delivering unparalled service and exceptional value to clinical trial partners and stakeholders.
- Actively striving to meet and exceed action items as discussed quarterly with direct supervisor
- Adhering to the study protocol and maintaining proper documentation according to the protocol, regulatory requirements, and internal SOP's.
- Preparing and administering study medication at the direction of the Investigator.
- Training site personnel on clinical procedures and CPR/Heartsaver.
- 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.
- Communicating the status of patients referred overall recruitment status, and clinical needs of the study to the investigators and Site Manager.
- Maintaining communication and building relationships with monitors from sponsoring companies through telephone contacts, written communication, on-site visits, and
- 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.
This position requires minimal physical effort. This position requires current LPN license for the state in which the site is located. This position does involve direct contact with patients. Occupational Health and Safety Risks include potential exposure to Bloodborne and airborne pathogens.
Clinical Research Nurse Coordinators should be certified or working towards certification in cardiopulmonary resuscitation.
This position may involve limited travel, including airplane travel, to attend investigator meetings.
Source - News & Observer