CLINICAL RESEARCH SPECIALIST

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

CLINICAL RESEARCH SPECIALIST
Anesthesiology-GVTU Division

Operations:
Maintain subject level documentation for minimal risk studies, or for other studies under direction. Schedule participants for study visits as directed. Prepare necessary documents, equipment, supplies, etc. Conduct and document visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs) for minimal risk studies or for other studies under direction. Follow procedures and documentation of study payment. Collect, prepare, process, ship, and maintain inventory of research specimens. Describe the various steps involved in handling IP. Assist with management of Investigational Products (IP) including arrival, storage, handling including requesting requisitions, inventory, and reordering Assist with maintenance of study level documentation. Define source document. Prepare for study monitoring and study audit visits.

Ethics:
Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority.

Data:
Map a protocol's data flow plan: data capture, storage, management, quality, and preparation for analysis Use Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations with little assistance. Enter data accurately. Score tests and measures according to protocol, and appropriate to role. Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol. Use required processes, policies, and systems to ensure data security and provenance. Assist in investigating incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Follow SOPs for data QA.

Science:
Leadership:
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements.

Study and Site Management:
Take part in site initiation/closeout visits as directed. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities

Communication:
Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution.

Description of Portfolio and Clinical Responsibilities:

Portfolio Management

Type of Research
This position is with the Anesthesiology CRU and works with healthy volunteers.


Requisition Number
401245037

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
802 CLINICAL RESEARCH SPECIALIST

Job Family Level
07

Exempt/Non-Exempt
Non-exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion,sexual orientation, or veteran status.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

Work requires an associates degree.

Experience

None above education listed above.

Auto req ID

88512BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

PI97509823