WVU Research Corporation Lead Screening Technician in Morgantown, West Virginia

Description Purpose This position provides clinical oversight of the study protocol as it relates to the qualification of eligible research subjects; screens potential subjects based upon study qualifications, according to standard operating procedures; facilitates the clinical laboratory assessments of enrolled subjects; and coordinates all data generated during the screening process.

Serves as a resource contact relative to study screening requirements. Independently uses professional concepts and techniques, as well as organizational policies to solve a wide range of moderate to complex problems in imaginative and practical ways. Depth skills, knowledge, and 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 basic objectives.

Duties & Responsibilities Responsibilities are functional in nature, and performed under limited supervision. Specific tasks include, but are not limited to: 1) Review all study protocols prior to the screening process to ensure knowledge in area of job function. 2) Participate in required screening procedures as outlined by the protocol, including but not limited to the completion of paperwork and update of volunteer information in the database, administer informed consent, collection of blood and urine samples, vital signs, ECG’s, or any other procedures as outlined in the protocol (evenings and weekends included). 3) Review and sort all screening documents at the completion of each daily screening session and prepare the documents for review by the investigator. 4) Ensure critical screening documents have been reviewed and signed by the investigator and compile charts for the Screening Nurse Manager, Clinical Research Nurse, and/or physician to review and determine acceptance into the study. 5) Assist with the QC of study screening documents as directed by the Screening Nurse Manager. 6) Assist with filing and entry of screening information into the database. 7) Review volunteer files for unresolved screening issues. 8) Provide a flexible schedule, as needed, to ensure that job description can be fully executed and for successful study conduct (evenings and weekends included). 9) Ensure compliance with all applicable regulations (ie. OSHA, FDA, State and Environmental Health) and ensure proper documentation of all procedures as required by clinical SOP's and Federal Regulations. 10) Other duties as assigned by the Screening Nurse Manager. 11) Oversee the reviews of all screening data in collaboration with the Clinical Research Nurse. 12) Assists in the QC of breakfast and dosing for approximately two to three studies per month (weekend mornings included). 13) Preparation of clinical Standard Operating Procedures for all procedures used during screening and clinical evaluations. 14) Coordinates and provides medical assessments of protocol specific labs through the duration of the study. 15) Assists the investigator in correspondence regarding follow-up of clinical judgments regarding results throughout the study. 16) Ensures that all documents used during screening follow protocol requirement. 17) Directs the Outreach Manager regarding specific protocol requirements for each study. 18) Execute the preparation of entrance screening documents, and any needed medical/laboratory supplies, i.e. pregnancy test vacutainer tubes, requisitions, special labs. 19) Maintains screening supplies provided by the reference lab. 20) Coordinate the assembly and maintenance of volunteer charts. 21) Execute the entry of volunteer screening information into the database.

Supervisory/Lead Role This position reports to the Screening Nurse Manager. 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) Patient Contact- having contact with a patient, or with potentially contaminated items including (but not limited to) blood and/or body fluids.

Requirements Requisite Qualifications Education and/or Experience 1) Completion of training in a vocational health occupation program; And 2) 5 – 7 years of clinical experience; Or 3) Equivalent combination of education and experience

Certifications, Licenses, Registrations 1) Certificate of training in a vocational health occupation program 2) CPR certified

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 establish and follow written standard operating procedures. 7) Ability to prioritize and manage multiple projects simultaneously. 8) 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. 9) Ability to develop constructive and cooperative working relationships with others and maintain them over time. 10) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. 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.

Requisition Number: 16-0089

Post Date: 7/15/2016

Title: Lead Screening Technician

Position Type: Full Time

Work Hours: 40 hpw

City: Morgantown

State: WV