||Clinical Trials Nurse Coordinator
Responsible for providing leadership and supervision of personnel and clinical operations. Participates in the development, coordination, and implementation of research and administrative strategies essential to the successful management of clinical trials
research conducted by principal investigators of the IDeA States Pediatric Clinical Trials Network (ISPCTN) and the Environmental Influences on Child Health Outcomes (ECHO) Network. Performs a variety of independent and collaborative duties involved in clinical
trial coordination and implementation, organization, oversight, documentation, tracking, data abstraction and collection and compilation of clinical research data.
Serves as a resource contact relative to management of ISPCTN and ECHO clinical research. 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.
Duties & Responsibilities
Responsibilities are managerial in nature, and performed under nominal supervision. Specific tasks include, but are not limited to:
1) Responsible for the coordination, delegation and evaluation of personnel and clinical operations of the WVU proportion of effort in ISPCTN and ECHO initiatives in conjunction with the Principal Investigators.
2) Supervises daily clinical activities of the research nursing staff and data managers and study coordinators.
3) Performs protocol procedures to ensure accurate, concise compilation of research data.
4) Attends study sponsored clinical coordinator meetings to ensure proper management of protocols.
5) Assures that patient visits are scheduled in accordance with protocol guidelines.
6) Collaborates with principal investigators to identify and resolve protocol implementation problems during design period; uses and revises/creates data forms to meet study requirements.
7) Works collaboratively with principal investigators to assess and manage toxicities and adverse effects as authorized by study protocol.
8) Instructs patients and/or family members, hospital and other university research personnel regarding research study requirements to ensure that all relevant individuals adequately understand study intent and procedures.
9) Participates in, and directs, organizational audits performed by monitoring and regulatory agencies.
10) Participates in the recruitment of potential protocols for activation from industry sponsored and other sponsoring organizations.
11) Participates in the patient recruitment efforts.
Reports to the Principal Investigators of the WVU ISPCTN. Normally receives no instructions on routine work, general instructions on new assignments. 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 will be assigned in this position. Guidance or supervision of others will be required.
Manual dexterity used in operating office equipment. Involves standing and bending in the assessment and treatment of patients. Prolonged periods of sitting and ability to walk short distances. This may require the use of elevators and/or stairs.
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.
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.
Education and/or Experience
1) Bachelor’s degree in an allied health discipline, or related medical field and/or RN degree
2) 5 – 7 years of experience working in a clinical setting and/or experience working in clinical trials, including 1 - 2 years of supervisory or program management experience
3) An equivalent combination of education and experience.
1) Certification as a Research Coordinator through the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) is required.
2) Valid driver’s license.
Skills, Knowledge Abilities
1) Skill in supervising personnel including organizing objectives, delegating responsibilities, training, evaluating subordinate effectiveness, and administering necessary discipline.
2) Excellent time and project management skills.
3) 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. Knowledge of the information and techniques
needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
4) Knowledge of animal tissues, cells, functions, interdependencies, and interactions with each other and the environment.
5) Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures and their history and origins.
6) Analytical demands – Involves oversight of a wide range of duties associated with the development, implementation and management of clinical research protocols.
7) Ability to prioritize tasks.
8) Must possess and apply knowledge of many different and unrelated processes and methods related to such areas as patient care, counseling and education; data collection, validation, entry, analysis, and reporting; treatment design, administration and modification;
human subjects protection and related issues.
9) Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
10) Ability to write routine reports and correspondence.
11) Ability to speak effectively before groups of customers or employees of the organization.
12) Ability to apply concepts of basic algebra and geometry.
13) Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume.
14) Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
15) Ability to deal with problems involving several concrete variables in standardized situations.
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.
Preferred Qualifications & Credentials
Education and/or Experience
1) Experience in pediatric clinical trials
- AA/EOE/Minorities/Females/Vet/Disability/E-Verify Compliant Employer.
- Please view Equal Employment Opportunity Posters provided by OFCCP
- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access
to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure
is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
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