Clinical Research Nurse II - Philadelphia, PA
Shift: 5 8's, M-F
Pay: $80,000 - $115,000
Responsibilities
- Coordinate and facilitate the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated.
- Provide leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety and data quality.
- The position will work closely with the members of the clinical research team to develop effective tools for close monitor and reporting of trials accrual, and coordinate the timely study activation and submission of protocol amendments.
- In addition, this position is expected to interact with the institutional investigators, other members of healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials.
- Flexibility in work schedule when possible must be maintained to ensure coverage of study responsibilities.
Qualifications
- Bachelors Degree (Required)
- Masters Degree (Preferred)
Licenses and Certifications
- RN-LIC - PA Registered Nurse License (Required)
- ONCC - Oncology Nursing Cert Corp (Preferred)
- CCRP - Cert Clin Research Prof (Preferred)
Experience
- 2 Years experience as a Clinical Research Nurse (Required)
- 2 Years experience in nursing with a focus on oncology (Required)
- 2 Years experience with oncology clinical trials (Required)
- General Experience and knowledge of chemotherapy administration (Preferred)
Required Skills
- Analytical Skills
- Customer Service Skills
- General Clerical Skills
- General Computer Skills
- Medical Terminology
- Microsoft Excel
- Microsoft Outlook
- Microsoft PowerPoint
- Microsoft Word
- Organizational Skills
- Strong Communication Skills
- Strong Interpersonal Skills
General Responsibilities
- Complies with all policies and procedures, and all applicable accreditation standards, laws and regulations, including those regarding patient confidentiality such as, but not limited to, Health Insurance Portability and Accountability Act of 1996, P. L. 104-191 ('HIPAA') and the rules and regulations implemented hereunder.
- Adheres to and promotes Hospital Safety Standards and the Safety Management Plan.
- Performs all job responsibilities in alignment with the core values, mission and vision of the organization.
- Performs other duties as required and completes all job functions as per departmental policies and procedures.
- Attends staff meetings and completes mandatory in-services and requirements and competency evaluations on time.
- Maintains current knowledge in present areas of responsibility (i.e., self education, attends ongoing educational programs).
- Demonstrates competency in providing patient care that is individualized relative to age, population, developmental, psycho-social-cultural and demonstrated needs.
- Wears protective clothing and equipment as appropriate.
Job Responsibilities:
Communication and Collaboration
- Acts as liaison between institutional investigators and pharmaceutical firms or their associates, national cooperative groups and institutional personnel.
- Maintains collaborative relationships with all research participants and research team members from all disciplines.
- Coordinates and assists with the evaluation of all clinical research studies managed by l institutional investigators by providing input feedback/comments to Research Review Committee, Principal Investigators, Project Manager Protocol Development and OCR Management.
- Communicates with Principal Investigators and OCR Management as needed on all study-related matters.
- Attends designated service line team meetings.
- In conjunction with Clinical Research Associate, schedules and attends Study Initiation Visits, Monitor Visits, and coordinate meetings to ensure all appropriate disciplines in attendance.
- Assists institutional investigators in evaluating the quality of research participant care and compliance to protocol requirements.
- Acts as a liaison for assigned service line leaders, investigators, nurses, pharmacists, pathologists, radiologists and other allied health care personnel.
Institutional Investigation Administration
- Assists institutional investigators with identification of potential research participants for the actively accruing clinical trials-prescreening.
- Assists investigators in evaluating/maintaining compliance to protocol requirements.
- Serves as a resource during site visits/audits by the, FDA, NCI, Pharmaceutical firms, or other agencies designated by sponsors (especially as related to appropriate consent, proper record keeping and quality assurance).
- Prepares reports and statistical information for all assigned clinical research protocols as required by the Institutional Review Board and NCI.
- Alerts investigators and appropriate personnel of communications regarding adverse drug reaction reports.
Research Participant Coordination
- Checks eligibility requirements to determine research participant eligibility for assigned studies.
- Ascertains pretreatment and eligibility requirements of protocol have been met prior to registration.
- Registers all research participants according to sponsor requirements.
- Documents research participant toxicities for clinic visits or phone interviews in compliance with applicable OCR SOP/SWP.
- Provides source documentation in the research participant's study chart as appropriate.
- Provides research participant/family members with instructions and education regarding the specific clinical research protocol(s) presented to them.
Research Study Coordination
- Creates protocol specific scheduling templates in the Online Appointment Slip System (OLAS) and schedules tests appropriately. Follows-up to ensure that all required tests, procedures or treatments were scheduled and completed as ordered.
- Prepares and submits reports of serious adverse events as required by the protocol, sponsor, IRB, FDA, NCI and OCR standard operating/work procedures in appropriate and timely fashion.
- Ensures that all baseline tests required by protocol are performed within specified timeframe and all eligibility requirements are met.
- Ensures adherence to the clinical research protocol and that all protocol deviations are documented carefully and submitted correctly and promptly.
- Monitors dosage modifications and treatment calculations in conjunction with treating physician and Investigator.
- Assists Protocol Support Lab with arrangements for collection and shipping of samples as required by protocol.
- Provides Regulatory Coordinator with copies of protocol correspondence generated by sponsor for inclusion into the investigator study file.
- Assists with completion of outstanding queries and case report forms as needed.
- Prepares and attends close out meeting with sponsor.
- Establishes archive files for team's study documents
Research Administration
- Designs, implements and manages a system for organizing, planning and controlling work flow related to all clinical research activities.
- Strictly adheres to policies and procedures to ensure the protection of research participant's rights, interests and well-being through efforts to comply with federal and institutional guidelines as represented by the IRB.
- Conducts continuous study analysis and evaluation of all clinical research activities and make recommendation to the institutional investigators or designated person(s) for improvements.
- Suggests improved methods for accomplishing research accrual and goals. − Collaborates with Clinical Research Associate, Project Manager Protocol Development, and/or QA Specialist in the planning and design of new forms to be used with clinical research protocols.
- Periodically reviews investigational drug logs and inventories with pharmacy staff to assure that appropriate documentation is maintained and that federal guidelines are being met.
- Assists with development of and compliance with department standard operating and standard work procedures and policies.
- Provides coverage to other Clinical Research Nurses/Coordinators in department as needed for planned and/or unexpected absences.
