Research Clinical Nurse Specialist

Drexel University; Philadelphia (Philadelphia County); On-site; USD 69,000 - 104,000; Full time

Job summary

Drexel University in Center City, Philadelphia, seeks a clinical research support specialist to assist investigators with regulatory compliance, IRB submissions, and study start-up activities across departments. The role involves coordinating data collection, training staff in GCP, managing protocols, and contributing to participant safety and data integrity throughout the trial lifecycle.

Travel to sites may be required and the position emphasizes collaboration with researchers, coordinators,

Qualifications

• Bachelor's degree in Nursing or equivalent.
• Minimum of 3 years of experience.
• Licensed as RN in Pennsylvania; BSN preferred.
• Experience in a clinical research environment.
• Knowledge of Good Clinical Practices (GCP).
• Knowledge of FDA regulations.
• Excellent organizational skills.
• Strong computer skills.
• Clinical skills: venipuncture, assessment, AE documentation.
• BLS/CPR and/or ALS certification.

Responsibilities

• Provide CNS and research support including regulatory activities and site start-up and close-out tasks.
• Document and report protocol/trial issues to IRB, Research Admin, and PI.
• Prepare IRB documents and study regulatory documents; assist with contracts and budgets.
• Coordinate site initiation and monitor visits; ensure audit readiness.
• Assist in recruitment and screening of subjects; monitor enrollment goals.
• Ensure subject safety and proper data capture; maintain logs and documentation.
• Obtain informed consent and conduct initial and ongoing subject assessments.
• Monitor lab results, manage specimens, and maintain safety compliance.
• Supervise and assist in training new coordinators and staff.

Skills

Nursing

Clinical Research

GCP

FDA Regulations

CPR

Education

Bachelor's Degree in Nursing

Tools

EMR

EDC

Job description

Job Summary

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.

Essential Functions

• 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 as noted below:
• 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.
• Resource Management:
  • 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
• Quality and Teamwork
  • 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.
  • Communication: Communicates (verbally and in writing) clearly, accurately and effectively.
  • Initiative: Volunteers assistance to others, seeks additional assignments when work is completed, is flexible and willingly accepts additional responsibilities.
  • Initiative: Makes all reasonable attempts to solve problems independently before turning them over to the supervisor with resolution proposal.
  • Judgment/Decision Making: Exhibits sound judgment and makes appropriate decisions in a timely manner.

Required Qualifications

• Minimum of a Bachelor's Degree in Nursing or the equivalent combination of education and work experience.
  • (Please review the Equivalency Chart for additional information.)
• 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

Physical Demands

• Typically sitting at a desk/table

Location

• Center City - Philadelphia, PA

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.