Clinical Research Nurse Navigator

7 days ago

Hackensack New Jersey, United States Hackensack Meridian Health Full time

Overview:
Our team members are the heart of what makes us better.


At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed.

With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community.


Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.


The Clinical Research Nurse Navigator is responsible for assisting the John Theurer Cancer Center (JTCC) Oncology Clinical Research administration grow and expand its clinical trial program throughout the network and beyond as defined by specific initiatives and/or agreements designed to do so.

This role will provide guidance, training, and coordination of all oncology clinical research activities within a particular assignment(s).

This role plays a pivotal role in assessing current and future status of existing affiliate clinical research programs and working together with the JTCC Oncology Clinical Research to further grow and expand such clinical research programs and participates in assessing, planning, implementing and evaluating Compliant Patient Care in assigned clinical research programs.

This role works under the general supervision of the JTCC Oncology Clinical Research leadership and jointly along with affiliate leadership and Principal Investigator(s) as required.


Responsibilities:
A day in the life of a Clinical Research Nurse Navigator at Hackensack Meridian Health includes:

The Clinical Research Nurse Navigator providing the Services shall: Reports to Clinical Research management leadership at JTCC.

Spends time at SJUMC's sites and works closely together with existing SJUMC clinical research physicians and staff.

Screens and identifies patients who could participate in ongoing clinical trials at JTCC.


Works to identify appropriate physician interest, patient populations, and the necessary clinical research infrastructure and processes to develop SJUMC as an affiliate clinical research site of JTCC.


Works together with all parties to: Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.

Recruits and evaluates potential study patients, and works with clinical research coordinator(s) to schedule required appointments and interviews.


Identifies 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.).


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 sponsors.


Instructs 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.

Assists investigators with consent process assuring study patients understand clinical trials and obtain written informed consent.

Educates study patients concerning informed consent procedures, HIPAA authorization.


Documents study patient's medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines.


Performs 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.

Maintains 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 patients.

Plans for study patient's appropriate care under the direction of a physician or advanced practice nurse.


Performs 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 APN.

Reviews and processes 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.

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.

Acts 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.

Participates in staff meetings and in-service education of nursing and medical staff.

Promotes safe patient care through assessing for patient, family or team member issues.

Plays an active role in resolution of patient or team member problems; conflict resolution.


Assures daily schedules within the division 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.

Identifies divisional problems and develops solutions to review with Oncology Research Administration.

Interacts in an appropriate and timely manner in conflict situations facilitating constructive resolutions and positive outcomes.

Serves as a role model for all research staff in all aspects of nursing and clinical research conduct (i.e professionalism, quality care)


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.

Other duties and/or projects as assigned.

Adheres to HMH Organizational competencies and standards of behavior.

Qualifications:
Education, Knowledge, Skills and

Abilities Required:
Graduate of a NLN/AACN accredited program in nursing.

Three years of progressive oncology nursing.

Three 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.


Proficient computer skills in platforms such as, but not limited to, Microsoft Office Suite, Google, etc., and voicemail is required.


Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.


Education, Knowledge, Skills and Abilities Preferred:
BSN.

Mandatory education on human subject research and GCP (CITI Training and Certification).

Knowledge of clinical trials and the regulation (local, state, and federal) of such.

Familiarity with basic scientific and healthcare principles and terminology.

Ability to work in a fast-paced environment and manage competing tasks and demands.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today

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