At Main Line Health, our Magnet® hospitals are well-known throughout suburban Philadelphia for our award-winning care. Our four acute care hospitals have been recognized by US News and World Report as among the top 10 Hospitals in the Philadelphia Region and the top 20 hospitals in Pennsylvania and we have been recognized by the Philadelphia Business journal as one of the top ten "Best Places to Work" in the Delaware Valley. With a history spanning more than 150 years, it’s one of the region’s most honored and respected academic healthcare institutions.
Lankenau Medical Center is seeking a full time Clinical Research Nurse. The Clinical Research Nurse coordinates and implements Phase II, III, and IV inpatient and outpatient clinical research studies. The Clinical Research Nurse coordinates all procedures, tests and follow-up visits according to the protocol which are required for enrolled research subjects, provides education to research subjects and staff regarding the investigational study, and promotes patient safety for all research related activities working collaboratively with the physician investigators and a multi-disciplinary team.
Essential Accountabilities: (Refer to department specific job description for additional details)
Coordinate the conduct of Phase II-IV clinical trials, including treatment, cancer prevention/control and cancer care delivery.
Reviews protocols and protocol specific informed consent forms with the study patients.
Consent patients for clinical trials. Follow GCP guidelines.
Demonstrate vigilance in patient safety, protocol compliance, and data quality.
Track all patient data in CREDIT, DDOTS.
Comply with all eCRF programs through National Cancer Institute (NCI), Research Bases and other sponsores.
Monitor patient care, conduct patient assessments, and document/report treatment side effects as required by protocol.
Complete case report forms (CRFs), and resolve data queries in a timely manner.
Obtain records required to complete CRFs.
Recruits and screen potential study patients as specified per available protocols.
Confirm patient eligibility and registration in accordance with protocol requirements.
Ensures the coordination of scheduling of protocol related patient visits and required testing per the protocol calendar.
Contacts Study Sponsor appropriately regarding clarifications of eligibility, concomitant therapy, and/or query responses as necessary.
Provide oversight of administration of study drugs or study interventions, as appropriate.
Interfaces with multiple departments, such as inpatient units, (i.e., Invasive Cardiology, Laboratory, Cardiothoracic Surgery, Radiation Therapy, Radiology, Pathology, Pharmacy, Medical Records, and Physicians offices), to accumulate necessary patient data and ensure source documentation and adherence to protocol requirements.
May attend tumor board and disease specific conferences to interact with multi-disciplinary team regarding active trials and patient eligibility.
Ensures adequate supply and distribution of protocol drugs.
Retrieves blood, urine, pathology specimens, and radiology studies and ships to sponsor per protocol guidelines.
Adheres to all Main Line Health, ICH, and FDA guidelines.
Performs other duties as assigned.
Prepares for and participates in quality assessment reviews (audits), including internal audits and Quality Improvement Projects.
Participates in the conduct of qualification visits, initiation meetings, monitoring visits and audits by the study sponsors, CROs, the FDA, and other entities as required.
Communicates with Principal Investigator for verification of data.
Attends investigator meetings and research base meetings as required.
Participates in continuing education, in-service programs and annual updates.
Maintains and distributes monthly list of available protocols.
Interfaces patient follow-up with appropriate institutional registries.
Implements patient/family teaching when appropriate.
Participates in patient recruitment activities, such as health fairs, screenings, and informational sessions, etc.
Prepare and process all regulatory documentation through the Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting.
Prepare and process all regulatory documentation with Research Bases, pharmaceutical companies and clinical research organizations (CROs).
Resolve regulatory related queries with IRB, study sponsors, and CRO.
Complies with the Main Line Health Confidentiality Policy.
Primary Customers or Key Working Relationships:
Patients, physicians, families, external agencies, industry personnel, clinical monitors, IRB personnel, departmental manager, employees within the department, employees outside the department, and other affiliates.
Education: Graduation from an accredited school of professional nursing required. BSN preferred. Strong written and verbal skills in the English language required.
Must be proficient with a computer including navigating websites, electronic data systems, Excel, Word, electronic medical records
Licensures & Certifications: Current Pennsylvania RN license. Hospital credentialing as required.
For LIMR Clinical Cancer Research /Cardiology: Successful completion of CITI Program & CPR certification. IATA & ACRP research certification encouraged.
For LIMR Clinical Cancer Research, and Cancer Centers:Five years oncology nursing experience. Clinical Trials /Clinical Research experience preferred.
Applicants must certify that they have not used tobacco products or nicotine in any form in the 90-days prior to submitting an application to Main Line Health. This will be verified during pre-employment testing. We are an Equal Opportunity Employer. Please, no agency calls