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Requisition Number 17-0094
Post Date 9/7/2017
Title Senior Clinical Research Specialist, RN
Position Type Full Time
Work Hours 40 hpw
City Morgantown
State WV
Description Incumbent must provide a flexible schedule, as needed, to ensure that job description can be fully executed and for successful study conduct (evenings and weekends included).

This position is responsible for providing leadership in the assessment of qualified subjects for inclusion in WVU CPRC studies, providing nursing tasks/nursing care activities in the screening and clinical conduct of studies and managing Clinical Research Nurses. Incumbent participates in the development, coordination, and implementation of research and administrative strategies essential to the successful management of clinical trials research conducted by WVU CPRC.

Duties & Responsibilities
1) Review all study protocols prior to the study to ensure knowledge in area of job function.
2) Attend sponsor initiation meetings and execute protocol review meetings with study unit staff.
3) Communicate specific protocol requirements for each study to the recruiting and clinical operations staff.
4) Gives information and obtains informed consent from research participants and documents appropriately.
5) Provide nursing support in screening and clinical conduct as needed.
6) Ensures accurate and timely data capture into study records.
7) Assist the investigator in the review of all screening data to ensure acceptance as identified per protocol.
8) Assists the investigator in correspondence regarding follow-up of clinical judgments regarding screening results.
9) Oversees correspondence with the sponsor regarding subject inclusion/exclusion criteria and screening deviations
10) Oversees the maintenance of the volunteer screening/enrollment logs, compiles the acceptance list, and updates the database.
11) Communicates pertinent information concerning the subject’s clinical status (project related) to the Study Unit Manager/Supervisor and PI.
12) Assist with the development of SOPs, guidelines, and work instructions.
13) 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.
14) Guarantees continuity of the research project by good time management.
15) Guarantees the confidentiality of the subjects.
16) Complies with local infection control policies.
17) Uses and interprets approved medical terminology and abbreviations.
18) Implements the nursing care for an individual or group of individuals by either direct nursing action or delegation.
19) Performs complex nursing tasks correctly and safely.
20) Demonstrates professional responsibility to subjects and clinical operations.
21) Follows clinical operations policies, standard operating procedures, and protocols and directs others to do the same.
22) Acts as trainer to study unit clinical support staff, signing off on required skill sets and training files.
23) Develop and streamline screening policies and procedures for study conduct.
24) Schedules physicians for conduct of physical exams and reviews reports and test results generated during screening for medical acceptability.
25) Participates in the project management of all studies as executed by the management team.
26) Schedules screening physical exams and exit exams as required per study protocol
27) Oversees the handling of participant charts for medical accuracy.
28) Participate in the test article dispensation including packaging, dosing and accountability in accordance with SOP’s and Federal Regulations as delegated by the PI.
Supervisory/Lead Role
This position reports to the Associate Director of Clinical Operations.

Physical Demands
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.

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 have been identified as possible reasons for EHS medical monitoring:
1) Contact with Human Blood –or Other Potentially Infectious Material (OPIM) includes human body fluid 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 physical or face to face contact with a patient, or having contact with potentially contaminated items including (but not limited to) blood and/or body fluids.
Requirements Requisite Qualifications
Education and/or Experience
1) Graduate of an accredited school of nursing;
2) 4 or more years of clinical experience;
3) An equivalent combination of education and experience.

1) Must be licensed in State of WV or eligible for licensure. Licensure is required in order to maintain position.
2) CPR certification

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.
4) 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.
5) 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.
6) Knowledge of animal tissues, cells, functions, interdependencies, and interactions with each other and the environment.
7) Knowledge of group behavior and dynamics, societal trends and influences, human migrations, ethnicity, cultures and their history and origins.
8) Intermediate computer skills required with the ability to work with database systems as needed.
9) Analytical skills which involve oversight of a wide range of duties associated with the development, implementation and management of clinical research protocols.
10) Ability to prioritize and manage multiple projects simultaneously.
11) Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
12) Ability to write routine reports and correspondence.
13) Ability to speak effectively before groups of customers or employees of the organization.
14) Ability to apply concepts of basic algebra and geometry.
15) Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume.
16) Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.
17) Ability to deal with problems involving several concrete variables in standardized situations.
18) Ability to adapt to change.

Behavioral Competencies
1) Technical skills – Strives to continuously build knowledge and skills; pursues training and development opportunities; assesses 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 approaches, 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 has the ability 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; exercises discretion and sound judgment; is tactful and responsible for own actions. Adheres to work schedule and complies with leave management responsibilities.

Preferred Qualifications & Credentials
1) ACLS certification
2) Clinical trials experience
3) Bachelor's degree
  • 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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