Per Diem Clinical Research Nurse (RN or LVN)
7 days ago
Montclair
Job Description Summary: The Clinical Research Nurse provides nursing standard of care in a research environment; Responsible for monitoring study participants, which includes collecting and reporting data on changes in their physical and mental status monitoring drug action and side effects, collecting lab sampling, dispensing, and accounting for investigational product assigned. Provides support to the clinical research coordinator in conducting inpatient portion of clinical trials; extent determined by experience, assignment of duties at the site delegation log, training, and license. Duties and Responsibilities: The Clinical Research Nurse: • Obtains, processes, and ships laboratory samples (e.g., blood, urine, etc.) as per protocol., • Assists and supports patient education on completion of diary, questionnaires and logs required in trial (if applicable), • Provides nursing standard of care in subjects admitted and seen in a clinical research setting, with the supervision of clinical research nurse-registered nurse (when applicable), • Ensures subjects’ safety and compliance with the protocol specific lifestyle guidelines., • Obtains and maintains intravenous access on subjects admitted., • Administers investigational product., • Assesses adverse events and drug reactions – seeks medical intervention for patients when appropriate., • Reports all adverse events (AEs), and serious or unexpected adverse events (SAEs) to the investigator and assisting the Investigator in reporting to the Sponsor/IRB all AEs/SAEs, as the protocol and regulations require, • Performs all protocol related procedures including, but not limited to vital signs, ECGs, phlebotomy, finger sticks, mouth swabs, spirometry, urine dipsticks, drug screens, pregnancy tests, etc., • Adequately documents study procedure collection via progress notes, adverse event information observed and/or reported along with procedures performed during clinical trial., • Obtains lab reports, procedure reports and ensure investigator reviews all lab results in form of full signature along with providing clinical significance to any out of range and/or abnormal value., • Dispenses and monitor allowed concomitant medication intake., • Dispenses and monitor cigarette intake., • Inventories of Medical supply, • Conducts Quarantine and recall procedures., • Maintains Crash cart inventory and contents., • Facilitates DRP and ER plans in the event of an emergency., • Attends Site initiation visits and/or training in-service for all protocols., • Maintains current Safe-t-pack biohazard training certification or IATA equivalent, (ACLS) advance life support certification, OSHA, and site’s SOP (SWP) training., • Has in-depth knowledge of company SOPs, ICH GCP guidelines and protocols assigned, specifically inpatient segment and safety criteria., • Assists in documentation of medical and surgical history, concomitant medication use, preliminary complaints, and lifestyle practices., • Documentation of inpatient activities, progress notes, adverse events observed and/or reported and performed during clinical trial., • Supports reinforcement of study restrictions, diets, and study guidelines, • Assists in obtaining lab reports, procedure reports and filing, specifically day -1 and/or unscheduled collected while inpatient., • Assists in preparation of collection tubes, vials, and study supplies for visits, including PK/PD set up., • Continuous observation and patient monitoring to ensure subjects’ safety and compliance with the protocol, restrictions, and specific guidelines., • Conducts assessment procedures as required by protocol (vital signs monitoring, electrocardiogram, etc.) under CRC and/or nurse supervision., • Maintains inpatient temperature Freezer, Refrigerator, and room logs., • Reports Temperature Excursions, • Occasional travel to Company sites, Principal Meetings, and/or Company meetings. Requirements: • Active Registered Nurse (RN) or Licensed Vocational Nurse (LVN) licensure., • Previous research experience and/or background are preferred., • ACLS certification for RNs, • Basic Cardiac Life Support, • GCP (Good Clinical Practice) – Must renew every 3 years, • Strong organizational and time management skills., • Excellent attention to detail and ability to maintain accurate records., • Effective communication skills, both written and verbal., • Ability to work independently and collaboratively in a team environment., • Understanding of ICH/GCP guidelines for human research, • Understanding of Code of Federal Regulations for Human Subject, • Computer Competency in Electronic Data Capture, • Understanding Phases I-IV drug development process., • Prolonged periods of sitting at a desk and working on a computer, • Must be able to lift 20 pounds at a time., • Exposure to human bodily fluids., • Laboratory Processing Procedures., • Subject/Patient Care, • Mid-level Computer use., • Weekend work schedules as needed., • Work is normally performed in a typical interior clinical/office environment., • Travel to sponsor required meetings as needed.