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Clinical Research Nurse

Company: WCG
Location: Hackensack
Posted on: June 22, 2022

Job Description:

General InformationLocation: Hackensack, NJOrganization: WCGJob Type: Full time - Temporary (6 months)Summary Of PositionDescription and RequirementsThe Charge Clinical Research Nurse is responsible for providing guidance, training, and coordination of the assigned oncology research divisions clinical research nursing team. This individual plays a pivotal role in coordinating and overseeing clinical operations of all assigned Clinical Research Nurse and Clinical Trials and participates in assessing, planning, implementing and evaluating Compliant Patient Care in clinical research studies. The Charge Clinical Research Nurse works under the general supervision of the Principal Investigator(s) and Oncology Clinical Research Administration.Vaccination RequirementTo be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 and flu vaccine by start date.Essential Requirements--- Graduate of a NLN/AACN accredited program in nursing.--- BSN (Bachelor of Science in Nursing)--- 3-5 years of progressive oncology nursing.--- 3-5 years oncology clinical research nursing experience.--- Adheres to the American Nurses Association standards.--- Strong attention to detail and customer service focus is required.--- Excellent communication, organizational, presentation, documentation, and interpersonal skills are required.--- Ability to work independently, or in a team, and handle multiple deadline-driven tasks in a dynamic environment is essential.--- Proficiency in Google Suite and Microsoft Office Suite (Word, Excel, and PowerPoint), email (Outlook), and voicemail is required.Essential Duties/Responsibilities--- Works together with and oversees all assigned Clinical Research Nurse to:o Assure that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.o Recruit and evaluate potential study patients, and works with clinical research coordinator(s) to schedule required appointments and interviews.o Identify the needs of the patient population served and modify and deliver care that is specific to those needs (i.e., age, culture, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.).o Review medical records for potential study patients and ensures that medical records include documentation of all laboratory test results and procedures and progress of study patients, following guidelines set forth by the protocol sponsors.o Instruct potential study patients, designated caregiver, physicians, nurse clinicians and other ancillary staff members involved in the care of the patient on aspects of patient's care, available trials, treatments and side effects.o Assist investigator with consent process assuring study patients understand clinical trials and obtain written informed consent.o Educate study patients concerning informed consent procedures, HIPAA authorization.o Document study patient's medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.o Perform nursing assessments and monitors study patient's progress during clinical trials; Tracks study patient's response by documenting on toxicity flow sheet, medication flow sheet and nurses' progress notes.o Maintain accurate, complete, up-to-date records on each patient participating in a clinical trial protocol in all applicable systems (i.e. electronic medical record, clinical trial management system, departmental and protocol specific databases).o Evaluate and develop study patient education materials and gives study patient and/or designated caregiver instructions on drug administration and other medical information; creates study specific calendars for study patients.o Plan for study patient's appropriate care under the direction of a physician or advanced practice nurse.o Notify principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effects.o Report all serious adverse events to sponsor and IRB of record according to established timelines.o Perform and/or oversee a variety of clinical duties that may include but not limited to: EKGs, processing/shipping of blood serum, urine and communicate results to PI and/or APN.o Together with the principal investigator, review and process all Safety Reports (INDs, SUGARs) as per institutional policies and procedures.--- Interacts with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocol.--- In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.--- Reviews study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.--- Act as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnel.--- Prepares and assists for sponsor monitor site visits and ensures all supporting documentation records are adequate and available for the visit; Meets with monitor at least once during each monitor site visit and resolves all issues found during visit.--- Assists the principal investigator in preparing for publication. Works with analysts and assists with queries related to data to evaluate the significance of collected data.--- Provides education to all departments and clinical areas where study is performed.--- Attends research meetings and conferences as required.--- Coordinates and manages the daily operations of the division in the abscess of administration.--- Promotes safe patient care through assessing for patient, family or team member issues.--- Plays an active role in resolution of patient or team member problem; conflict resolution--- Assures daily schedules within the division to supports safe patient care and assists in maintaining appropriate staffing within the division in compliance with acuity, etc.--- Interprets supports and communicates HMH & JTCC policies, standards and procedures--- Efficiently identifies divisional problems and develops solutions to review with Oncolgoy Research Administration.--- Acts as a liaison for research nurses for concerns between departments and facilities and collaborates with the JTCC Management Team on inter and intra departmental issues that may occur when dealing with other members of the organization.--- Provides employee supervision to further enhance quality care and gives feedback to staff--- Identifies patient care issues and collaborates with the JTCC Management Team to initiate change.--- Assumes special projects as assigned--- Lifts a minimum of 5 lbs., pushes and pulls a minimum of 5 lbs. and stands a minimum of 6 hours a day.--- Adheres to the standards identified in the Medical Center's Organizational Competencies.Experience/Skills--- Demonstrated ability to create and follow research project-related supporting documents.--- Proven ability to schedule and coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline.--- Demonstrated ability to report on the status of project deliverables and draft and submit project updates to the study sponsor.--- Strong clinical and analytical skills. Proven ability to evaluate and assess subject's suitability for inclusion into studies, obtain informed consent, determine patient eligibility and coordinate patient enrollment.--- Excellent time management and organizational skills. Strong interpersonal skills with the proven ability to communicate effectively.Preferred Education, Experience, Skills, Licenses or Certifications--- BSN Preferred--- Mandatory education on human subject research and GCP (CITI Training and Certification).--- Knowledge of clinical trials and the regulations (local, state, and federal).--- Current valid NJ State Professional Registered Nurse license.--- Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to perform sedentary work, which includes sitting for long periods and occasionally required to lift 25lbs. Further guidance on physical activities, requirements, visual acuity, and working conditions is available in HR.WCG is proud to be an equal opportunity employer - Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law.

Keywords: WCG, Hackensack , Clinical Research Nurse, Healthcare , Hackensack, New Jersey

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