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Requisition Number 17-0053
Post Date 5/19/2017
Title Clinical Trials Nurse
Position Type Full Time
Work Hours 40 hpw
City Morgantown
State WV
Description Purpose
Participates in the development, coordination, monitoring, and implementation of research strategies essential to the successful management of clinical trials research conducted by principal investigators. Performs a variety of independent and collaborative duties involved in clinical trials including, but not limited to, documentation, tracking, data abstraction and collection and compilation/entry of clinical research data.

This position provides program, as well as direct internal and external client support services. Responds to inquiries and independently resolves matters of low to moderate complexity. 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 performed under general supervision. Specific tasks include, but are not limited to:
1) Coordinates, delegates, and evaluates clinical operations of the WVU proportion of effort initiatives in conjunction with the Principal Investigators.
2) Collaborates daily with the research nursing staff, 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) Educates 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.
8) Participates in organizational audits performed by monitoring and regulatory agencies.
9) Participates in the recruitment of potential protocols for activation from industry sponsored and other sponsoring organizations.
10) Participates in the patient recruitment efforts.

Supervisory/Lead Role
Reports to the Principal Investigators and Pediatric Clinical Trials Nurse Coordinator. Normally receives minimal instructions on routine work, general instructions on new assignments. Follows set methods and procedures on new assignments. General sharing of knowledge and team participation is expected in the role.

Physical Demands
Manual dexterity used in operating office equipment. Involves standing and bending in the assessment and treatment of patients. Prolonged periods of sitting/standing and ability to walk short distances. This may require the use of elevators and/or stairs.

Work Environment
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) 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 related medical field and/or RN degree
And
2) 3 - 5 years of experience working in a clinical setting and/or experience working in clinical trials
Or
3) An equivalent combination of education and experience.

Certifications/Licensures
1) Valid driver’s license.
2) Have or obtain CITI training and Good Clinical Practice Training within 60 days of hire

Skills, Knowledge Abilities
1) Excellent time and project management skills.
2) 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 and physicians.
3) Analytical demands – Involves coordinating a wide range of duties associated with the development, implementation, and reporting of clinical research protocols.
4) Ability to prioritize tasks.
5) Must possess and apply knowledge of many different and unrelated processes and methods related to Pediatric clinical trials.
6) Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
7) Ability to write routine reports and correspondence.
8) Ability to speak effectively before groups.
9) Ability to calculate figures and amounts such as proportions, percentages, and volume.
10) Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
11) Ability to deal with problems involving several concrete variables in standardized situations.

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.

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 here.
  • 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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