Research Clinical Nurse Specialist

Drexel University•Philadelphia, PA

3d•$69,070 - $103,600•Onsite

About The Position

This position will provide clinical research support services to researchers within the assigned departments. This individual will support such researchers providing the required elements necessary to retain regulatory, clinical and ethical compliance with all aspects of the clinical trial process. In addition, this position will assist in providing research training for Drexel University clinical research, including Good Clinical Practices (GCP), at designated departments and facilities.

Requirements

Minimum of a Bachelor's Degree in Nursing or the equivalent combination of education and work experience.
Minimum of 3 years of experience.
Graduation from an approved school of professional nursing, with BSN minimum degree, and licensed by the State of Pennsylvania as a registered nurse, 3 years of nursing experience preferred.
Experience working in a clinical research environment, inpatient and/or outpatient settings
Knowledge of Good Clinical practices
Knowledge of FDA regulations
Excellent organization skills are essential
Confident computer skills
Expert clinical skills, including, but not limited to Nursing Assessment skills, venipuncture, documentation of assessment and adverse events (AE’s), medical history.
Current Basic Life Support/CPR and/or Advanced Life Support Certification

Responsibilities

Conducts full CNS and research duties for assigned trials including Regulatory, IRB, and Study Start up and close out activities, staff training, recruitment, and retention of study subjects.
Promptly documents and reports any observed protocol/trial issues to the IRB, Research Administrator and PI.
Ensures established procedures are followed in reviewing the collection of clinical data and the administration of clinical trials.
Prepares and submits IRB documents under the direction of the Principal Investigator (PI), Research Administrator and prepares study related regulatory documents.
Assists in development of contracts and budgets under direction of PI and Research Administrator.
Review and ascertain invoice accuracy before remittance.
Coordinates and participates in the pre-site, site initiation and interval monitoring visits. Remain 100% audit ready.
Conducts trial search and feasibility in collaboration with PI.
Participates in Investigator Meetings requiring some travel.
Coordinates study initiation and assists with planning and design of source documents for protocol; adhering to study protocol.
Supports ongoing recruitment of volunteer subjects for clinical research; screens subjects for protocol eligibility and participation; and monitors enrollment goals.
Provide participant compensation and/or stipends via clinical conductor.
Ensures human subject safety.
Maintain screening and enrollment logs and communicate results to PI.
Organizes and facilitates with the PI- Subject Informed Consent from study participant and documents appropriately.
Completes an initial subject assessment and ongoing assessments as per protocol utilizing interview, observation, and Physical Assessment skills.
Obtains Vital Signs and performs phlebotomy, IV infusion, ECG, and other tests where applicable; some tests and procedures may require training specific to an individual study.
Administers study drug and/or Investigational Product as per protocol.
Monitors participants’ labs and communicates results to PI in a timely manner; utilizing proper procedures, prepares and ships lab specimens as needed.
Maintain laboratory logs and safety compliance including temperature and centrifuge records.
Monitors and completes accurate source documentation and electronic Data capture as per protocol on all participant records, drug accountability, test devices and clinical supplies.
Completes all required trainings for Sponsor’s, Drexel and Hospital Electronic Data Capture and EMR.
Utilizes data resources external to research area, as well as develops and facilitates productive working relationship with the study monitor, ancillary personnel, PI, study staff and clinical staff.
As able, will supervise and assist in the development and education of new coordinators, research staff and physicians involved in clinical research.
Maintain CITI training and certification.
Demonstrates the ability to plan effectively by recognizing and setting priorities and completing assignments in a timely manner.
Organizes work effectively, adjusts well to changes in work schedule, workflow, and priorities.
Seeks to utilize equipment, time, supplies, phones and other clinical research resources properly and efficiently.
Operates in a collaborative manner and is open and flexible to the ideas of others.
Seeks to provide the highest quality service in an accurate, thorough, and timely manner.
Consistently adheres to Drexel University and department policies, procedures and standards regarding conduct, attendance, tardiness and appearance.
Communicates (verbally and in writing) clearly, accurately and effectively.
Volunteers assistance to others, seeks additional assignments when work is completed, is flexible and willingly accepts additional responsibilities.
Makes all reasonable attempts to solve problems independently before turning them over to the supervisor with resolution proposal.
Exhibits sound judgment and makes appropriate decisions in a timely manner.