WVU Research Corporation Quality Control Specialist in Morgantown, West Virginia
Description Purpose The purpose of this position is to provide materials used to develop study notebooks and required documents for data capture. This position will verify that the credentials of the study staff are current, that the data collected are accurate, and that the Quality Control (QC) procedures are followed to assure the integrity and accuracy of the Source documents. This position requires stringent and dedicated attention and focus to the accuracy of Case Report Forms to the Source documents. Position will be applying careful analysis of capturing minor and major errors within the submitted documents for QC, and will be working appropriately with the Study Coordinators on the proper resolution and documentation of the discrepancies.
Provides study related support, as well as active engagement in the QC process, for any corrective and preventative program, as well as direct internal and external client support services. Position responds to inquiries and independently resolves matters of low to moderate complexity. This position works within the framework of Good Clinical Practices (GCP) and Good Documentation Practices (GDP) Practices. Responsibilities require some judgment, resourcefulness and originality, but diverse guides and precedents are usually available to apply or adapt to the circumstances. Work effort has considerable impact on client services, program and project image, with potential legal liabilities.
Duties & Responsibilities Responsibilities are functional in nature, and performed under general supervision. Specific tasks include, but are not limited to: 1) Developing study notebooks to follow the clinical plan of the study and to support data collected for completion of Case Report Forms (CRFs). 2) Verifying the accuracy of CRFs to source documents and participates in quality control checks of study documents. 3) In conference with the members of the Study Unit Operations (i.e., Study Unit Manager, the Study Unit Supervisor, Study Coordinator), incorporating improvements and requirements to fully capture data as required per the protocol. 4) Developing new documents where required. 5) Supervising the quality control student assistant, if applicable. 6) Conducting a timely review of study notebook after submission to quality control by the Study Monitor. 7) Conducting follow-up quality evaluation of documents provided by study staff as appropriate (i.e. Query Tracking by Department and employee). 8) Functioning as a backup Study Monitor to ensure coverage of scheduled studies (includes weekend days as needed). 9) Assisting in quality control checks on study drug prior to each phase of the study. 10) Supporting the final check of screening documents for accepted volunteers. 11) Participating in quality control checks of study documents.
Supervisory/Lead Role This position reports to the Associate Director of Clinical Operations. Normally receives minimal instructions on routine work, general instructions on new assignments. Supervision of others is not required; however, sharing of knowledge with others and team participation is expected in the role. Program, project or activity lead responsibilities will occur or be assigned in this position.
Physical Demands Activities require manual skill to provide and/or alter services and/or products. Manual dexterity used in operating office equipment. Prolonged periods of sitting, and the ability to walk short distances is required. Use of elevators and/or stairs is routine. Activities are predominantly non-manual though some manual work not directly involved with altering or transporting of products may be included.
Work Environment Work is performed in a normal clinic/hospital setting. Exposure to diseases, chemical and biologic hazards is possible. The incumbent must comply with all safety procedures and clothing/equipment requirements. Incumbent is responsible to know and comply with all safety 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 Infections Material (OPIM)- includes human body fluids other than feces, urine, tears and sweat. 2) Human Pathogen and Biological Research- (BSL2+/3)- 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.
Requirements Requisite Qualifications Education and/or Experience 1) Bachelor’s degree in an allied health discipline, or a related field; and 2) 2 – 4 years’ medical experience in regulatory aspects of industry and government sponsored clinical trials; or 3) An equivalent combination of education and experience.
Skills, Knowledge, Abilities 1) Working knowledge of regulatory aspects of industry and government sponsored clinical trials including (Institutional review board) IRB regulations. 2) Working knowledge of developing (investigational new drug) IND safety reports. 3) Skilled at problem solving. 4) Excellent oral and written communication skills. 5) Skilled at creating and implementing effective Quality programs. 6) Strong work processing skills and understanding and the ability to handle stress and work under pressure. 7) Skilled at using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. 8) Strong time management skills and ability to prioritize and manage multiple projects simultaneously. 9) Computer proficiency, including Microsoft Office. 10) Demonstrated ability to work effectively in both cross-functional teams and independently is required. 11) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. 12) Ability to write reports, business correspondence, and procedure manuals. 13) Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 14) Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. 15) Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. 16) Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. 17) Must be able to read large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.
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) Bachelor’s degree in nursing, biology, chemistry, or related clinical experience. 2) Clinical Research Professional (CCRP) or related certification
Requisition Number: 16-0061
Post Date: 5/6/2016
Title: Quality Control Specialist
Position Type: Full Time
Work Hours: 40 hpw