We are seeking an on-site Clinical Research Nurse to become part of our dedicated CCAY Clinical Research team!

This position is full-time (Monday-Friday) on-site position.

What you will be doing...

Under the guidance and supervision of the Principal Investigator, the Clinical Research Nurse is responsible for assuring that the integrity and quality of the clinical research is maintained and conducted in accordance with Good Clinical Practice Guidelines, applicable federal, state and local regulations. The Clinical Research Nurse implements recruitment procedures for potential participants, ensures compliance with protocols, overall research and clinical objectives as well as maintains accurate and timely documentation.

ESSENTIAL FUNCTIONS – JOB DUTIES: The following duties are considered essential to the job. Qualified individuals must have the ability – with or without reasonable accommodation – to perform the following duties.

1) Assists PI and other team members as needed in the development of plans, time lines and processes for research studies, contributes to the ongoing review and any necessary modifications to approved protocols.

2) Coordinates and participates in the pre-site study initiation visits. Coordinates study initiation and assists with planning and design of source documents for protocol while adhering to study protocol.

3) Supports ongoing recruitment of patients for research in accordance to protocol requirements; screens potential patients for eligibility and participation; monitors enrollment goals.

4) Presents trial concepts and details to the patients, participates in the informed consent process and enrolls patients on protocol.

5) May disburse investigational drug and provide patient teaching regarding administration; maintains investigational drug accountability.

6) Anticipates the physiologic and psychosocial problems of research participants and prepares for them using evidence-based nursing expertise.

7) In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.

8) Responsible for accurate and timely collection, documentation, entry and reporting of trial data.

9) Remains audit ready.

10) Provides education to patients, families and clinic staff regarding research protocol and investigational agents.

11) Ensures patient is properly scheduled for study visits based on study protocol.

12) Collects, processes, and assists in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions).

13) Conducts blood draws, EKGs, and obtains vitals from patients.

14) Enters and maintains case report forms per FDA guidelines and reviews them against the patient’s medical record for completeness and accuracy.

15) Obtains and maintains GCP and IATA training as requirement for research.

16) Attends routine meetings and other meetings related to the clinical research; stays abreast of information and any changes to study protocol.

17) Participates in required training and education programs.

18) Maintains regular and punctual attendance.

19) Complies with all practice policies and procedures including CCAY’s Code of Conduct.

SECONDARY FUNCTIONS – JOB DUTIES: The following duties are considered secondary to the essential functions listed above.

1) Responsible for tracking and monitoring payments associated with all clinical trials.

2) Performs other duties as assigned.

EDUCATION/REQUIREMENTS/SKILLS/EXPERIENCE

Specific education, certification, and licensure:

• Nursing diploma, Associate’s Degree in nursing required or higher preferred.
• Current licensure as a Registered Professional Nurse is required, issued by the PA State Board of Nursing.
• SoCRA or ACRP certification preferred or completion within two to three years of hire date.

Essential Job-related Experience:

• Minimum two to three (2-3) career experience in nursing.

Preferred Job-related experience:

• Two to Three (2-3) years of experience in clinical research, preferably oncology.

Essential Job-related Skills:

• Strong written, verbal and problem-solving skills
• Excellent project management and organization skills
• Experience at interpreting medical charts, abstracting data from medical records
• Ability to organize and coordinate multiple patients’ research activities to adhere to protocol requirements.
• Ability to work in a rapidly changing, multiple-demand setting.
• Ability to prioritize a large volume of work and meet deadlines efficiently.
• Attention to detail and accuracy