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Job type: Permanent

Discipline: Clinical Scientist, Clinical Outsourcing, Clinical Evaluation

Location: United States

Clinical Research Nurse - Permanent - Onsite

Proclinical Staffing is seeking a Clinical Research Nurse to join a top medical program. This is a permanent role located in Philadelphia, PA.

Primary Responsibilities

This position will report directly to the DVL Lead Clinical Research Nurse and work directly with Physician Investigators ("PI") on clinical research performed. This area of research requires dedicated attention and care to ensure subject safety and well-being. The successful candidate will comply with all policies relating to UPHS, JCAHO, GCP and other regulatory standards.

Skills & Requirements:

7-10 years adult clinical experience
Preferably adult oncology experience
Preferably not required some sort of clinical research experience. Not bench work or nursing research experience.
Phase 1-4 clinical research experience.
Experience with EPIC EMR is a bonus.
Excellent communication skills

The Clinical Research Nurse will:

Work in collaboration with Research Team Leaders and Principal Investigators with initiating study procedures for new IITs and industry-sponsored clinical trials. Manage all aspects of Phase I - IV clinical trials. Participate in the conduct of audits by study sponsors, CROs, the FDA, the Eastern Oncology Group, CTSRMC, and other groups.
Work directly with physicians to design, set-up and execute clinical trials. May be required to speak at investigator meetings or site initiation visits for investigator-initiated trials ("IITs") where physician is the national PI. Assist in analyzing data to determine response and clinical outcomes; assist with literature reviews; contribute to preparation of study abstracts, posters, manuscripts and grant applications.
Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, infusion, radiology, Advanced Practitioners, triage, inpatient and pharmacy. Provide in-service and support to infusion, CHPS or inpatient staff as appropriate. Provide ongoing service education updates to all investigators and HUP staff that have eligible participants for clinical research trials
Care for subjects in all age groups from young adult through geriatrics. Establishes nursing plan of care in collaboration with the PI and study team and in accordance with research guidelines and GCP. Coordinate activities of oncology team in caring for subjects. Administer or provide oversight of administration of medications, chemotherapeutic drugs, biologic response modifiers, cellular immunotherapies and other treatment agents or study interventions, as appropriate.
Review all clinical and laboratory data and adverse events, reporting in real-time to the Principal Investigator (PI) for assessment and review, and communicate with medical staff regarding protocol-specific management of toxicities and adverse events.
Triage any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications, and symptom management within clinical scope and level of expertise and referring other questions to the PI or medical team in order to obtain guidance or assistance.
If needed, collect, review and report timely, valid, accurate study data within the timelines specified by the Clinical Trials Agreement. Coordination may also include: transporting specimens, submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC, IBC, CHPS) for initial approval, continuing reviews and for approval of any amendments.
Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs.
This position will require the research nurse to have a variable schedule. Research subjects are seen in the clinical setting during early morning and early evening hours as well as daytime visits. Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel.
This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to supervisor.
Work directly with physicians to design, set-up and execute studies. Be responsible for writing investigator-initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where collaborating physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; contribute to the preparation of study abstracts, posters, manuscripts and grant applications.
Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) clinical trials and registries within the Developmental Therapeutics (DVL) Research Team.
Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs. Responsible for functional supervision of non-licensed personnel assigned to work with the nurse. Act in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support (e.g., regulatory submissions and data entry). Participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Participate in working groups within the disease-site team that will maximize the efficiency and quality of research performed, including developing SOPs. Act as a mentor to newly hired staff.
Represents the DVL Research Team when meeting with Medical Science Liaisons, current and future research collaborators, and prospective donors; assists physician and unit manager in coordinating development plans. Participation in national meetings, as well as department meetings and committees. Act as a facilitator and speak at community events organized by physicians in collaboration with non-profit organizations.

If you are having difficulty in applying or if you have any questions, please contact Kylie Williams at (+1) 267-523-2542 or k.williams@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDCR