TechWerks is looking for a full-time Nurse Coordinator to add to our growing team in Silver Spring.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1) Protocol Coordination (to include but not limited to):
a) Organize and prioritize all activities associated with conducting laboratory- and field-based human use protocols.
b) Review and understand protocol, ensuring applicable regulations and guidelines are followed.
c) Coordinate space and supplies with appropriate personnel.
d) Recruit volunteers for protocols, to include determining volunteer population availability, advertising venues, and discussions with potential volunteers via telephone or e-mail.
e) Obtain and document informed consent of potential volunteers as delegated by study principal investigator.
f) Administer questionnaires to determine eligibility and per protocol data collection procedures.
g) Volunteer advocate and associated duties.
h) Test article accountability to include consultation with Pharmacy Personnel and Principal Investigator (PI) for drug handling, dispensing, dosing time and dosing intervals.
i) Documentation, to include gathering, preparing and maintaining appropriate information per applicable FDA regulations and ICH guidelines, source and case report forms (CRF), participant rosters, standard operating procedures (SOP), etc.
j) Enter required data on CRFs and audit records for accuracy, resolve discrepancies, correct as necessary.
k) Coordinate with external and internal monitors, additionally maintain compliance with specific protocol, SOPs, regulations and guidelines.
l) Computer literate to create forms, reports, etc.
m) Provide clinical expertise/knowledge to other staff in the department.
n) Monitor volunteer safety, compliance and health status as needed and follows through with the appropriate physician.
o) Review clinic schedule for adequate staff coverage of all protocol activities and communicate any concerns to Lab Manager.
p) Participate in sample collection and processing per protocol to include insertion of IVs and catheters.
q) Review sample collection and processing instructions with Phlebotomists to ensure all requirements are followed.
r) Participate in administration of study product as outlined in IRB approved research protocols “Roles and Responsibilities” section.
s) Prepare adverse event and unanticipated problem summaries per protocol.
t) Prepare deviations log.
u) Communicate pertinent study observations to the PI and branch leadership.
v) Complete continuing review reports (CRR) and final reports for review by the PI.
2) Provide assistance to Behavioral Biology Branch as needed on proposal writing projects and provide assistance with all job-related progress reports/technical reports
3) Maintain a safe work place ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
4) Performs light duties and other related duties as required and assigned.
● Registered nurse licensed in state of Maryland.
● Minimum 3 years work experience in clinical research setting as a research coordinator.
● Nursing experience with the insertion and maintenance of peripheral venous catheters (PVC); utilizing infection control sterile principles, procedures, and standards of care.
● Strong leadership/management skills – will be responsible for coordinating research staff and study participants.
● CCRC certification is a plus, though the certification must be obtained within 12 months of employment for all noncertified applicants.
● Able to work both independently and in a team setting.
● Excellent communication, organization and prioritization skills.
● Intermittent physical activity including bending, reaching and prolonged periods of sitting and or standing.
● May be required to work at different collaborating facilities (e.g., NIH, NiCoE) and be responsible for own transportation.
● Must be available to be scheduled based on operational and business needs (to include overnights and weekends during study execution).
● Required Knowledge, Skills and Abilities: knowledge of applicable highly complex scientific procedures and techniques relating to position. Background in polysomnography is a plus.
● Physical Capabilities: work may involve long periods of standing, interacting with research volunteers, and handling of chemicals and/or hazardous biological material.
● Work Environment: laboratory environment primary; may also include hospital (e.g., NIH, NiCoE) environment; will require working evenings and weekends; some shifts may be greater than 8 hours in duration.
● Must be able to work independently following a brief period of specific technical training.
WORK ENVIRONMENT: laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.