Rn-Medical Research Coordinator

Clinical Research Nurse

Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines. Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?

To provide assistance in coordinating multi-specialty national and international clinical trials. To screen, identify and when appropriate, enroll and monitor patients who are candidates for selected Doylestown Hospital Research Protocols. To be a liaison and provide direction to the physicians for planning, implementation, protocol compliance, follow-up and reporting of results of the research protocol

Responsibilities:

• Knowledge of the research process and application of FDA requirements in conducting medical research. Assesses plans, implements, documents, coordinates and manages patient care related to all clinical trial protocol parameters and within the scope of the Nurse Practice Act.
• Perform screening of new patients for the purpose of identification of potential research candidates for selected research programs.
• Evaluation of the patient eligibility for clinical research protocols.
• Verify that pre-study evaluations have been conducted according to the requirements of the study.
• Ensures compliance to all governmental and institutional requirements and regulations pertaining to the conduct of the study by obtaining (or assisting the physician in obtaining) informed consent for entry into research protocols.
• To do eligibility assessment by reviewing the Inclusion and Exclusion Criteria for the study.
• Determine the eligibility of new patients for the assigned clinical research protocol and when appropriate, register and assign appropriate intervention be it by randomized IWRS/ IVRS/ RAMOS or direct assignment of eligible, consenting patient into these protocols.
• Ensure appropriate documentation of consented patients medical history information and disease status for determining starting point of protocol therapy.
• Insure proper and timely submission of required pathology, radiotherapy, angiography of laboratory material that maybe required for core/central monitoring.
• Establish and maintain systems to ensure patient and physician compliance with protocol parameters including treatment administration, dose modifications, proper scheduling of return visits, x-rays, scans and blood work.
• To determine exact doses of study medication for each patient, to assure patient study medication compliance, to prepare standard orders for protocol treatment and coordinate treatment orders with the physician and nursing associates.
• Complete DH Research Medication Administration Form with dual signatures for each Medication administered to a study participant.
• Ensure all women, of childbearing capability have pregnancy tests completed with date and time annotated in the Source Documents prior to study drug administration.
• To monitor the patients condition as outlined in the research protocol; to provide interim physical assessment of active patients and to then provide assessment findings to the investigating physician and nursing associates as required.
• Reports all adverse and serious adverse drug/device reactions to the appropriate agency (IRB) or study group according to established guidelines.
• Consult with the investigating physician, the patients attending and Primary Care physician regarding appropriate modifications of the research therapy as result of ineffectiveness, side effects, or adverse reactions.
• Provide detailed information of risk, benefits, and alternative therapies pertaining to protocol treatments so as to fully inform patients prior to their consent, to provide information of protocol availability and protocol rationale to referred patients and their families.
• Contributes to the development of a written, evolving plan of care based on nursing assessment, medical plan of care and patient need. The plan is initiated according to departmental standards.
• Recognizes legal responsibilities and functions within limitations as specified by the Nurse Practice Act, federal and institutional research standards.
• Maintains regulatory training requirements as written within the Research Departments SOP.
• Demonstrates initiative and self-direction in completion of assigned responsibilities.
• Acts as a resource to hospital associates on protocol specific matters.
• Safely administers medications and treatments as ordered according to hospital policy and formulary, using the five rights of the patient pertinent to safe medication administration.
• Safely handles various types of drugs and body fluids using knowledge of appropriate precautions.
• Demonstrates the ability to perform with clinical proficiency in crises and medical emergencies.
• Is flexible in working evening, night, and weekend hours to order to meet research protocol needs.
• To effectively communicate with all hospital disciplines (physicians, nurses, administration, laboratory, radiology, medical records, accounting/billing, community relations, medical staff offices associates) patients, families and the general public in achieving excellence in patient care.
• Utilizes interpersonal communication techniques that show a willingness to accept and give constructive feedback for the purpose of promoting professional excellence.
• Develop source documents and research educational materials.
• To provide patient education by being thoroughly familiar with the techniques, risks and benefits of the research protocols and be capable of providing procedure education to patients and families.
• Conduct in-services to hospital associates on research related study topics.
• Available via pager around the clock for research protocol related questions.
• Communicates, consults and shares pertinent information with associates according to established channels and lines of authority at all times.
• Notifies the Research Director and/or Medical Director in a timely manner of any significant information or incidents.
• Always handles customers, patients, guests, visitors, hospital associates and other work contact with courtesy, tact and diplomacy.
• Maintains open communication with protocol Sponsor and/or CRO, to assure an ongoing relationship with the sponsor/CRO for future research protocols.
• Must be able to work in a constantly changing environment.
• Resource and mentor to students interested in conducting clinical research.
• Utilizes analytical skills to direct and complete all research-related activities and maintain clinical competency according to research specific standards.
• Always carries out assigned job duties and responsibilities as outlined in the job description through own initiative as directed by the Director of Research.
• Adopts and practices safe work habits and acts within security guidelines at all times.
• Obtain, maintain and abstract data required for protocol analysis as requested by the Principal Investigator and reported on required electronic case report forms as dictated by protocol parameters in a timely and accurate manner.
• Assists in the maintenance of Clinical Trial Management System (CTMS), ensuring that visits and support staff are accurately logged.
• Completes required annual hospital in-services as per hospital policies (RAHE, BLS).
• Demonstrates ability to organize time/materials and set priorities.
• Demonstrates competency in maintaining specific technological skills required by job category: computer skills-MS Office (including Word, Access, Excel, Power Point), etc.
• Maintains patient confidentiality and HIPAA.
• Demonstrates clinical proficiency and maintains a knowledge base of hospital policies, and research protocols.
• Assists in establishing databases for research protocols as appropriate.
• Functions as a resource person and mentor for the staff.
• Continues work-related education and training as indicated by attendance at workshops, seminars, and in-service programs.
• Participates in Quality Improvement activities as related to research protocols.
• Participates in protocol conference calls as needed.
• Maintains confidential research related regulatory materials and patients charts for 15 years following the completion of the research protocol in a locked, limited accessible area.
• Always safeguards and protects confidential information according to established Federal Code of Regulations and HIPAA.
• Attends work, reports absences and lateness, and requests time off according to the established policies.
• Seeks out and utilizes the input of others when participating in or developing a project or program. Takes responsibility for key parts of the project or program.
• Upholds standards of Medical Research Department.
• Identifies professional goals, which reflect own strengths and weaknesses and seeks assistance for improvement of performance.

Actively participates in and supports departmental and organizational quality initiatives and goals.

Participates in Quality Improvement activities as related to research protocols.

Complies with Quality initiatives related to the Standard Operating procedures.

Complies with Quality initiatives related to correspondence with primary care physicians and specialists.

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