- Data Management
- Nursing Experience
- Clinical Trials
- Clinical Research
Clinical Research Nurse BSN preferred- Cardiovascular, Critical Care and Research exp preferred - (46919)
The Lankenau Hospital Research Institute, known today as the Lankenau Institute for Medical Research (LIMR), opened in 1927. It was the first research center in the nation dedicated primarily to the study of cancer and the first to discover a genetic defect that contributed to human cancer, thus launching the modern era of molecular genetics in cancer research. LIMR is the research center for Lankenau Medical Center and Main Line Health and is part of Lankenau’s magnificent campus, located in Wynnewood, PA.
Today, under the leadership of Dr. George C. Prendergast, LIMR scientists are focusing their research on cancer, as well as cardiovascular, autoimmune and gastrointestinal diseases, regenerative medicine, and population health. LIMR is expanding studies of disease-modifier genes, pioneering nanotechnology-based gene therapies, as well as new pharmacological agents to treat cancer; exploring cardiovascular disease focused on hypertension and cardiac arrhythmias; and using basic and preclinical findings to create new prognostic and therapeutic tools for clinical use.
In addition to our research, LIMR also sponsors several educational initiatives that encourage students and physicians to engage in research activities within our laboratories.
As we look ahead to the next decades our researchers are actively working to take LIMR’s discoveries from bench to bedside through the creation of an exceptional environment where translational research has greater impact in both commercial and clinical settings. To learn more about LIMR visit the website at www.LIMR.org.
Why work for Main Line Health’s Lankenau Institute for Medical Research?
We are committed to providing exceptional care with empathy and compassion for people at all stages in life. Our Diversity, Respect and Inclusion Initiative celebrates our differences and our similarities. Ultimately, we want everyone to feel respected for who they are.
Main Line Health has consistently been ranked among the best places to work by Best Places to Work in PA and the Philadelphia Business Journal. We also rank among Modern Healthcare's top 100 places in the nation to work in health care. Our physicians and employees speak highly of the work environment at Main Line Health.
Turn your job into a career by joining Main Line Health!
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)
Coordinates the conduct of Phase II-IV clinical trials specific to the department and Clinical Research Center research program.
Reviews protocols and protocol specific informed consent forms with the study patients.
Assists the Principal Investigator (“PI”) in the consenting process following Good Clinical Practice (GCP) guidelines.
Demonstrates vigilance in patient safety, protocol compliance, and data quality.
Tracks all patient data in the appropriate clinical trial management system.
Obtains records required and complete case report forms (CRFs) or Electronic Data Capture system (EDCs), resolves data queries in a timely manner and complies with all eCRF programs through National Institutes of Health (NIH), Research Bases and/or other sponsors.
Monitors patient care, conducts patient assessments, and documents/reports Adverse events as required by protocol.
Recruits and screens potential study patients as specified per available protocols.
Reviews patient eligibility criteria 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 the appropriate Study Sponsor and PI regarding clarifications of eligibility, concomitant therapy, and/or query responses as necessary.
Provide oversight for acquisition of investigational study product (i.e. drug or device), monitoring of investigational study product and documentation of administration of product as well as study interventions, as appropriate.
Provides oversight, documentation and coordination of all protocol defined testing, e.g. radiographic imaging and laboratory testing.
Interfaces with multiple departments, such as inpatient units, Invasive Cardiology, Laboratory, Cardiothoracic Surgery, Radiation Therapy, Radiology, Pathology, Pharmacy, Medical Records, and Physicians’ offices to gather necessary patient data and ensure source documentation and adherence to protocol requirements.
Attends, as assigned, specific meetings and/or conferences to interact with multi-disciplinary team regarding active trials and patient eligibility.
Ensures adequate supply and distribution of protocol drugs as required
Retrieves study related materials such as blood, urine, pathology specimens, cardiology and radiology studies, prepares and ships to sponsor per protocol guidelines.
Adheres to all Main Line Health, International Conference on Harmonization (ICH), and Food and Drug Administration (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, clinical research organizations (CROs), the FDA, and other entities as required.
Communicates with Principal Investigator and study investigators for verification of data.
Attends study related 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.
Additional Regulatory Responsibilities (as assigned):
Prepares and processes all regulatory documentation including but not limited to documentation processed through the local or central Institutional Review Board (IRB) and other entities as required, including amendments, continuing reviews, and adverse event reporting.
Resolves 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.
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 Cancer Centers OCN/CCRP preferred.
For LIMR Clinical Cancer Research /Cardiology and other specialties: Successful completion of CITI Program & CPR certification. IATA & ACRP research certification encouraged.
Five years nursing experience in the oncology, cardiology and/or related area and Clinical Trials/Clinical Research experience preferred.
DEPARTMENT-SPECIFIC COMPETENCIES: Demonstrates excellent oral and written communication skills and knowledge of the principles of data management. Must be detail-oriented and capable of prioritizing responsibilities. Demonstrates ability to work as part of a team as well as independently.
Individual may be required to travel to Main Line Health Hospitals or manage protocol requirements which may occur over a weekend, as applicable to the study protocol.
AGE-SPECIFIC COMPETENCIES: N/A
Equipment Used: Medical equipment specific to the requirements of various clinical trials, Personal Computer, Photocopier, Fax Machine, Scanner, and Telephone.
Exposures: Takes proper precautions as outlined in Main Line Health Safety Manual, Infection Prevention and Control Policy and Procedure Manual, Fire and Emergency Manual, Cytotoxic Safety Manual and Radiation Safety Policies. May be subject to potential injuries such as needle sticks, muscle strains and skin irritations/burns when working with volatile or caustic substances.
If interested, please apply online at https://www.mainlinehealth.org/careers , Job ID 46919.
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
Primary Location: United States-Pennsylvania-Wynnewood
Work Locations: Lankenau Institute Med Resrch 100 Lancaster Avenue Wynnewood 19096
Job: Staff Nurse
Organization: M063811290-MnLnHrtCtr-Clin Institutional
Shift: Day Job
Employee Status: Regular
Job Posting: Jan 15, 2019, 9:14:38 AM
Shift Details: 1