WVU Research Corporation Clinical Research Nurse in Morgantown, West Virginia
Purpose This position supports the Clinical & Pharmacologic Research Center (CPRC) and is responsible for the development, continuation, performing and completion of the research project under supervision. The primary responsibility of this position is for execution of all nursing tasks/nursing care activities and training.
This position serves as a resource contact relative to clinical trials research. Independently uses professional concepts to solve a wide range of moderate to complex problems. Interpretive abilities, as well as some creativity, are required to successfully perform duties. Work effort often addresses non-routine matters within established protocol, guidelines, and/or policies. Work effort has significant impact on client services and operations, producing moderate to major organizational, legal and financial results and/or liabilities. Position duties may require oversight of projects or programs, including coordination of work by others providing support of public health and welfare objectives.
Duties & Responsibilities Responsibilities are functional in nature, and performed under limited supervision. Specific tasks include, but are not limited to: 1) Performs all screening, eligibility and enrollment procedures. 2) Check inclusion/exclusion requirements to determine subject eligibility for protocols. 3) Registers research subjects per sponsor and/or proper guidelines. 4) Maintains subject study logs/screening logs/enrollment logs. 5) Gives information and obtains informed consent from research participants and documents appropriately (under supervision of and together with PI) – if applicable. 6) Extracts data from a variety of sources to complete pre-study forms, flow sheets, case report forms and any other special forms for subjects. 7) Ensures accurate and timely data capture into study records. 8) Performs subject interviews at study visits to collect data required by protocol. 9) Enters data for specific visits by EDC, or other means as applicable. 10) Assists PI/PM with any special requests for data retrieval for ongoing studies. 11) Records and documents protocol deviations. 12) Records and documents AE’s and SAE’s; discusses evolution of AEs and SAEs with PI/PM. 13) Deals with queries together with the QC department and the research team members as required. 14) Documents drop-outs of the study. 15) Executes research project procedures in accordance with SOPs, ICH/GCP guidelines and other applicable regulatory requirements. 16) Administers authorized study medications as directed by the Research Physician. 17) Maintains accurate records of medications dispensed and returned (drug accountability). 18) Ensures laboratory samples are drawn and processed per protocol and associated SOPs. 19) Ensures all tests and procedures are obtained in a timely and safe manner per protocol guidelines. 20) Observes subjects and acts as appropriate to the situation. 21) Communicates pertinent information concerning the subject’s clinical status (project related) to the Study Unit Manager/Supervisor and PI. 22) Documents reasons for not carrying out protocol requirements. 23) Guarantees continuity of the research project by good time management. 24) Guarantees the confidentiality of the subjects. 25) Complies with local infection control policies. 26) Uses and interprets approved medical terminology and abbreviations. 27) Works in other departments as deemed necessary by management. 28) Assesses Standard Operating Procedures for unit. 29) Evaluates completed case report forms for completeness, accuracy and compliance to protocol, if applicable. 30) Communicates information concerning subject’s needs or significant changes to Study Unit Manager/Supervisor or PI. 31) Implements the nursing care for an individual or group of individuals by either direct nursing action or delegation. 32) Performs complex nursing tasks correctly and safely. 33) Demonstrates professional responsibility to subjects, department and to the study unit. 34) Follows study unit policies, standard operating procedures, and unit protocols and directs others to do the same. 35) Acts as trainer to study unit clinical support staff, signing off on required skill sets and training files. 36) Attends and participates in department staff meetings as required.
Supervisory/Lead Role This position reports to the Associate Director of Clinical Operations. Normally receives no instructions on routine work, and general instructions on new assignments. Typically determines methods and procedures on new assignments. General sharing of knowledge and team participation is expected in the role. Program, project, or activity lead and work coordination responsibilities may occur or be assigned in this position. Guidance or supervision of others may be required.
Physical Demands This position requires manual dexterity used in operating office equipment; requires standing and bending in the assessment and treatment of patients; prolonged periods of sitting and the ability to walk short distances. Work activities may require the use of elevators and/or stairs. Activities are predominantly non-manual though some manual work may be included.
Work Environment Work is performed in a normal clinic/hospital setting. Exposure to diseases, chemical and biologic hazards is possible. Incumbent is responsible to know and follow all safety precautions and procedures.
The following items have been determined as possible job exposures of this position requiring WVU EHS medical monitoring: 1) Contact with Human Blood or Other Potentially Infectious Material (OPIM)- includes human body fluids other than feces, urine, tears and sweat. 2) Human Pathogen and Biological Research (BSL2+/3)- for those working with or in proximity to certain biological agents. 3) Patient Contact- having contact with a patient, or with potentially contaminated items including (but not limited to) blood and/or body fluids. 4) Scientific Research- research with nanoparticles, lasers, anesthetic, fuels or mining, aquatic or diving, etc.
Requisite Qualifications Education and/or Experience 1) Graduate of an accredited school of nursing (BSN, RN); And 2) 5 years of related medical experience; Or 1) An equivalent combination of education and experience.
Certifications, Licenses, Registrations 1) Must be licensed in State of WV or eligible for licensure. 2) CPR certification
Skills, Knowledge, Abilities 1) Strong working knowledge of clinical trials research: a. Must possess and apply knowledge of many different and unrelated processes and methods related to such areas as: patient care, treatment design administration and modification, counseling and education data collection, validation, entry, analysis, and reporting, human subjects protection and related issues 2) Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. 3) Intermediate computer skills and ability to work with database systems. 4) Excellent time management skills 5) Excellent communication skills. 6) Ability to prioritize and manage multiple projects simultaneously. 7) Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Position requires excellent customer service skills and the ability to communicate effectively with patients and families; pharmaceutical company personnel; regulatory and monitoring agency personnel; and, internal staff members. 8) Ability to develop constructive and cooperative working relationships with others and maintain them over time. 9) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. 10) Ability to write reports, business correspondence, and procedure manuals. 11) Ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events). 12) Ability to analyze information and evaluate results to choose the best solution, solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 13) Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. 14) Ability to develop specific goals and plans, to prioritize, organize and accomplish tasks independently and through others.
Behavioral Competencies 1) Technical skills – Strives to continuously build knowledge and skills; pursues training and development opportunities; assess strengths, weaknesses, and shares expertise with others. 2) Problem solving – Gathers and analyzes information, identifies problems, develops alternatives, uses reason even when dealing with emotional topics and works well in groups and resolves matters timely. 3) Internal & External Customer Service – Manages difficult or emotional matters with objectivity and openness; responds promptly to needs and requests for service and assistance; meets commitments and dates, notifies others if change occurs; provides, solicits and applies feedback; and builds goodwill through balanced contributions, positive approach, respect and support of others. 4) Communications – Demonstrates group presentation skills, participates in meetings, listens and gets clarification, is responsive and speaks clearly and persuasively in positive and negative situations. Writes and edits clearly and informatively, varies style to meet needs, presents numerical data effectively, and able to read and interpret written information. 5) Organizational Support – Aligns work and develops strategies to meet organizational goals; seeks to improve and promote quality; demonstrates accuracy and thoroughness; and upholds organizational expectations and values. 6) Self-Management – Responds to management direction; resourcefully adapts to changes in work environment and circumstances; responds well under pressure and manages competing demands; takes calculated risks, asks for and offers help when needed; exercise discretion and sound judgment; is tactful and responsible for own actions. Adheres to work schedule and complies with leave management responsibilities.
Preferred Qualifications & Credentials Education and/or Experience 1) ACLS certification
Requisition Number: 16-0075
Title: Clinical Research Nurse
Post Date: 6/10/2016