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The Clinical Research Nurse is responsible for coordinating and overseeing clinical research operations for all assigned clinical trials and participates in assessing, planning, implementing and evaluating Compliant Patient Care in clinical research trials. The Clinical Research Nurse carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials.
ResponsibilitiesA day in the life of a Clinical Research Nurse at Hackensack Meridian Health may include:
Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potentialAssures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely mannerActs as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocolInteracts with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocolIn 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 studyReviews study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinatorRecruits and evaluates potential study patients, and works with clinical research coordinator to schedule required appointments and interviewsIdentifies the needs of the patient population served and modifies and delivers 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.)Reviews 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 sponsorsInstructs 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 effectsAssists investigator with consent process assuring study patients understand clinical trials and obtains written informed consentEducates study patients concerning informed consent procedures, HIPAA authorizationDocuments study patient¿s medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelinesPerforms 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 notesMaintains 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)Evaluates and develops 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 patientsPlans for study patient¿s appropriate care under the direction of a physician or advanced practice nurseNotifies principal investigator of any adverse events and serious adverse events, including evidence of drug toxicity or unexpected side effectsReports all serious adverse events to sponsor and IRB of record according to established timelinesCoordinates research activities not limited to: scheduling laboratory tests, radiology testing and other medical examsPerforms and/or oversees a variety of clinical duties that may include but not limited to: EKGs, processing/shipping of blood serum, urine and communicates results to PI and/or APNTogether with the principal investigator, reviews and processes all Safety Reports (INDs, SUGARs) as per institutional policies and proceduresAct as principal investigator's representative as appropriate. This may include communicating with sponsors and their representatives, the IRB and other medical personnelMaintains accurate, complete, up-to-date records on each patient participating in a clinical trial protocolEnsures study patient's clinical trial related activities are billed appropriately and reconciles drug study account records with research finance personnelPrepares 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 visitDevelops case report forms and/or databases for physician initiated studies as neededAssists the principal investigator in preparing for publication. Works with analysts and assists with queries related to data to evaluate the significance of collected dataProvides education to all departments and clinical areas where study is performedAttends research meetings and conferences as required QualificationsEducation, Knowledge, Skills and Abilities Required:
BSN requiredMinimum of 3 years clinical nursing experience or 1 year of clinical nursing experience with an additional 2 years of clinical research experienceAdheres to the American Nurses Association standardsStrong attention to detail and customer service focus is requiredExcellent communication, organizational, presentation, documentation, and interpersonal skills are requiredAbility to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essentialProficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platformsReview and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulationsProficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms
Education, Knowledge, Skills and Abilities Preferred:
National Certification in area of specialty preferred when eligible.Licenses and Certifications Required:
NJ State Professional Registered Nurse License.AHA Basic Health Care Life Support HCP Certification within 60 days of entering position.
Licenses and Certifications Preferred:
Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYERAll qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
Our NetworkHackensack Meridian Health (HMH) is a Mandatory Influenza Vaccination Facility
All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
As a courtesy to assist you in your job search, we would like to send your resume to other areas of our Hackensack Meridian Health network who may have current openings that fit your skills and experience.