WVU Research Corporation Clinical Research Coordinator in Morgantown, West Virginia
Purpose This position is critical to the successful conduct of clinical trials. This position is a key role in the completion of all tasks associated with the studies. The incumbent will oversee the conduct of assigned studies as defined per study protocol, and will execute the study from IRB approval through submission of the final report and Case Report Forms.
This position supervises and coordinates the activities of others and is responsible for the performance of various duties in support of clinical trials. Performs functional operation duties; acts independently, using professional concepts and organizational objectives to effectively address moderate to complex matters. Position duties may require creativity, depth SKAs and interpretive abilities. Work effort has considerable impact on personnel and workflow with potential legal liabilities.
Duties & Responsibilities Responsibilities are supervisory in nature, and performed under limited supervision. Specific tasks include, but are not limited to: 1) Coordinate all aspects of assigned study. 2) Supervise the study staff on assigned studies. Direct supervision (i.e. recruitment, selection, performance management, time management) of the Lead Clinical Research Technician and Clinical Research Technicians; and, functional oversight of the Health Care Associates assigned to the study is required. 3) Ensure protocol review by independent contractors assigned to the study. 4) Participate in the preparation of study documents/notebooks for use in study execution. 5) Ensure the execution of studies following the protocol. 6) Complete the Study Monitor Checklist for assigned studies. 7) Conduct first QC audit of consent. 8) Supervise and/or execute the set up for each study. 9) Execute and/or oversee the entering of entrance and exit physical exams into database. 10) Conduct QC of study specimen containers prior to study initiation. 11) Ensure the collection of data and follow the data through the QC process throughout the study. 12) Ensure maintenance of freezers and the changing of temperature charts at least weekly. 13) Follow QC procedures throughout the study to ensure accurate capture of all study data and proper handling of study specimens as prescribed by GCP and the sponsor. 14) Complete data accuracy checklist at the conclusion of each period. 15) Execute transcription of required Case Report Forms. 16) Act as back up for transcription of Clinical Study Report. 17) Ensure resolution of outstanding issues regarding data from each period. 18) Participate in the process of collecting Adverse Experiences/Events and completing the documentation process and follow-up. 19) Participate in the execution and design of QC process of study documents for all studies 20) Review all study protocols prior to study conduct to ensure knowledge in area of job function. 21) Attend sponsor initiation meetings and execute protocol review meetings with study unit staff. 22) Build study sessions or perform study sign off in the database. 23) Work closely with the IT department to ensure required authorizations are obtained for database related needs such as templates, schedules, sessions and randomizations for all studies. 24) Ensure catering services are scheduled for the study unit. 25) Perform quality control check on final study reports, including required tables. 26) Function as sponsor contact and oversee specimen collection, specimen storage, specimen paperwork, release and shipment. QC shipment paperwork. 27) Ensure the maintenance of DSU equipment, inspections, validation and documentation as per the GCP requirements and regulatory standards. 28) Develop and streamline DSU policies and procedures for study conduct. 29) Assist with the preparation and revision of SOP’s, guidelines, and work instructions for the study unit. 30) Maintain OSHA compliance in the study unit. 31) Participate in the quality control of test article dispensation including packaging, dosing and accountability in accordance with SOP’s and Federal Regulations as delegated by the PI. 32) Ensure compliance with all applicable regulations (i.e. OSHA, FDA, State and Environmental Health) and ensure proper documentation of all procedures (i.e. equipment inspections and freezer charts) as required by clinical SOP's and Federal Regulations. 33) Works closely with the Data Science Team in the proper progress of the Study Report (CSR) in assuring that the Study Report is meeting its timelines and milestones. 34) Actively participates in the resolution and tracking of queries issued against the Study report with respect to the internally-generated (QA) versus external-generated (sponsor) queries.
Supervisory/Lead Role This position reports to the Associate Director of Clinical Operations. Normally receives no instructions on routine work, limited instructions on new assignments. Typically determines methods and procedures on new assignments. Supervision of others will be required; and, 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 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.
Requisite Qualifications Education and/or Experience 1) Bachelors’ degree in an allied health discipline, or a related medical field, or completion of training in a vocational health occupation program; 2) 5 - 7 years of medical related experience, including 1 - 2 years supervisory experience Or 3) An equivalent combination of education and experience.
Certifications, Licenses, Registrations 1) 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 and the ability to prioritize and manage multiple projects simultaneously. 5) Excellent communication skills. 6) Ability to establish and follow written standard operating procedures. 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) Bachelor’s degree in nursing.
Requisition Number: 16-0028
Title: Clinical Research Coordinator
Post Date: 2/19/2016