Research Clinical Nurse Specialist

Job Summary

This position provides clinical research support services to researchers within the assigned departments, ensuring regulatory, clinical, and ethical compliance throughout the clinical trial process.

About the Role

Supports researchers by conducting full CNS and research duties, including regulatory, IRB, and study start-up and close-out activities, staff training, recruitment, and retention of study subjects.

Responsibilities

• 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.
• Aids in the development of contracts and budgets under direction of PI and Research Administrator.
• Reviews and verifies invoice accuracy before remittance.
• Collaborates in pre-site, site initiation, and interval monitoring visits.
• Coordinates and participates in investigator meetings, requiring some travel.
• Supports ongoing recruitment of volunteer subjects for clinical research; screens subjects for protocol eligibility and participation; and monitors enrollment goals.
• Provides participant compensation and/or stipends via clinical conductor.
• Maintains human subject safety.
• Organizes and facilitates subject informed consent from study participants and documents appropriately.
• Completes initial and ongoing assessments as per protocol using interview, observation, and physical assessment skills.
• Administers study drug and/or investigational product as per protocol.
• Maintains laboratory logs and safety compliance including temperature and centrifuge records.
• Maintains accurate source documentation and electronic data capture as per protocol on all participant records, drug accountability, test devices, and clinical supplies.
• Utilizes data resources external to research area, as well as develops and facilitates productive working relationships with the study monitor, ancillary personnel, PI, study staff, and clinical staff.
• Supervises and assists in the development and education of new coordinators, research staff, and physicians involved in clinical research.
• Maintains CITI training and certification.

Requirements

• 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.
• Sets and utilizes equipment, time, supplies, phones, and other clinical research resources properly and efficiently.

Qualifications

• 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 and 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.

Physical Demands

Typically sitting at a desk/table.

Additional Information

This position is classified as Exempt, grade L. Compensation for this grade ranges from $69,070 to $103,600 per year. Please note that the offered rate for this position will vary based on the successful candidate’s qualifications and experience, department budget, and an internal equity review.

Applicants are encouraged to explore the Professional Staff salary structure and Compensation Guidelines & Policies for more details on Drexel’s compensation framework.

For information about benefits, please review Drexel’s Benefits Brochure.

Special Instructions to the Applicant

Please make sure you upload your CV/resume and cover letter when submitting your application. A review of applicants will begin once a suitable candidate pool is identified.