Clinical Research Technician

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Company: West Virginia University Research
Location: Morgantown, WV
Date Posted: May 3, 2015
Source: West Virginia University Research


Provides clinical nursing support for the collection and organization of data from Phase I clinical research studies additionally the position will assist the Clinical Research coordinator in operations, compliance and logistical support.

This position serves as a resource contact and 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. Position duties may require oversight of projects or programs, including coordination of work by others providing support of basic objectives.

**Duties & Responsibilities

Responsibilities are functional in nature, and performed under limited supervision. Specific tasks include, but are not limited to:

1) Review Study Protocol and sign the confidentiality statement.

2) Assist with review and signing of Study Specific Informed Consent if assigned.

3) Sign the Study Scheduling Sheet.

4) Assist with checking volunteers into the unit for assigned procedures.

5) Ensure that all subjects are dressed in appropriate scrubs, have wrist bands secured, and have name visible name tags on.

6) Assist with general observation of volunteers during confinement.

7) Ensure appropriate measures to assure subject safety.

8) Provide required meals and fluid to subjects as outlined in the protocol and document on appropriate source documents.

9) Function as a bathroom monitor as needed.

10) Collect listing of volunteer requests and provide to Study Monitor.

11) Collect urine samples and assist with urine processing per protocol.

12) Ensure that all subjects have wristbands on with dosing times added.

13) Ensure that subjects are ready for blood collections and prepare supplies as needed.

14) Ensure subjects are ready for dosing and perform mouth checks as directed by the Study Monitor.

15) Participate in the process of collecting adverse events and in the conduction of screening procedures.

16) Perform vital sign collections, ECGs, glucometer testing, and pulse oximeters testing as needed.

17) Collect blood samples by heparin lock or venipuncture as needed; flush and remove heparin locks as needed.

18) Process blood samples as needed.

19) Demonstrate proper use of oxygen tank and AED.

20) Verbalize understanding of emergency cart and needed supplies.

21) Follow treatment orders as directed by the study physician.

22) Ensure that duties are performed as outlined in the protocol and recorded accurate and legible on source documents.

23) Check source documents for accuracy and completeness at the end of your shift.

24) Assist with general housekeeping procedures.

25) Report any protocol deviations to the Study Monitor.

26) Report any screening deviations to the Screening Department.

**Supervisory/Lead Role**

This position reports to theStudy Coordinator; however, it may be assigned to, and is responsible to assist as needed, on studies overseen by positions other than their immediate supervisor.The incumbent normally receives no instructions on routine work, and general instructions on new assignments. Typically 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 may occur or be assigned in this position. Guidance or supervision of others may be required.

**Physical Demands**

This positionrequires standing and bending in the assessment and treatment of patients;requires manual dexterity used in drawing blood and processing the samples; 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 and a processing lab. Exposure to diseases, body fluids, chemical and biologic hazards is possible. Incumbent is responsible to know and comply with all safety procedures.


**Requisite Qualifications

_Education and/or Experience


1) Completion of training in a vocational health occupation program;

2) 5 – 7 years of clinical experience;


3) An equivalent combination of education and experience.



_Certifications, Licenses, Registrations


1) CPR certification_




_Skills, Knowledge, Abilities


1) Working knowledge of appropriate patient assessment techniques.

2) Must demonstrate expert skills in phlebotomy.

3) Ability to handle a variety of tasks simultaneously and effectively.

4) Ability to prioritize and use excellent time management skills.

5) Ability to work independently or as a team member.

6) Ability to adapt to a changing environment.

7) Skilled at following policy and procedures related to bio-specimen collection, preparation and storage.

8) Should possess good written/oral communication, and have knowledge of basic computer applications using Word and Excel.

9) Basic chemistry lab skills as demonstrated by passing a high school chemistry course.

10) 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.

11) Knowledge of the information and techniques needed for diagnosis and treatment. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.

12) Knowledge of appropriate bio-specimen collection and processing techniques.

13) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations.

14) Ability to write reports, business correspondence, and procedure manuals.

15) Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

16) Ability to develop constructive and cooperative working relationships with others and maintain them over time.

17) Ability to apply concepts of basic algebra and geometry.

18) Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume.

19) 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.

20) Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

21) Ability to develop specific goals and plans, to prioritize, organize and accomplish tasks independently and through others.

22) Ability to learn how to reproducibly use a pipette and maintain safe lab practices



_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

1) Licensed practical nurse OR EMT/Paramedic with current WV license or certification_


2) ACLS certification_


3) Clinical research experience_


4) Bachelor’s degree _


*Requisition Number:* 14-0097

*Post Date:* 4/29/2015

*Title:* Clinical Research Technician

*City:* Morgantown

*State:* WV

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