Clinical Research Coordinator

Location
North Carolina, United States
Posted
19 Sep 2018
End of advertisement period
19 Nov 2018
Ref
401464964
Contract Type
Permanent
Hours
Full Time

Medicine-Infectious Diseases

Job Description

Operations:

Screen participants for all studies independently. Maintain subject level documentation for all studies independently Schedule participants and conduct visits for minimal risk studies independently. 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 Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Evaluate processes to identify issues related to recruitment and retention rates. Conduct and document consent for participants in a variety of studies independently Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information independently Complete and submit AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. 

Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently. 

Ethics:

Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. 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. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs).  Assist with the coordination of efforts of external monitoring boards. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial

Data:

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. Recognize and report vulnerabilities related to security of physical and electronic data. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing 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. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team.

Study and Site Management:

Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Take part in site initiation/closeout visits as directed. 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.

Requisition Number 401464964
Location Durham
Duke Entity MEDICAL CENTER
Job Code 1201 CLINICAL RESEARCH COORDINATOR
Job Family Level 52
Exempt/Non-Exempt 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, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging.

Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

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

  1. Completion of a Bachelor's degree. 
  2. Completion of an Associates degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination). 

Special Skills

The ideal candidate would possess experience with inpatient investigational drug clinical trials. Prior  experience in the hospital setting would be a benefit.

Auto req ID

103515BR

Similar jobs

Similar jobs