CLINICAL RESEARCH SPECIALIST, SR

Location
Durham, NC
Posted
May 12, 2017
Institution Type
Four-Year Institution

CLINICAL RESEARCH SPECIALIST, SR
Phase 1 Clinical Research

Occupational Summary
Perform a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research for the Duke Cancer Institute's (DCI) Oncology Clinical Research Unit (OncCRU) for the Phase I Team. Participate in day-to-day operations related to the collection, compilation, and documentation of clinical research data.

Work Preformed
Clinical Research Operations- Screen, schedule, conduct visits, and consent participants in minimal risk studies, including documentation of consent in the electronic medical record. Prepare documents, equipment, or supplies for research visits. Conduct and document visits and protocol-specific testing or interviews according to study protocol, operational plans of clinical departments, and Standard Operating Procedures (SOPs). Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs.

Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Collect, prepare or process adverse event information under supervision. Provide input for adverse events reports. Assist with maintenance of study level documentation. Prepare for study monitoring or study audit visits.

Provide input for Institutional Review Board (IRB) documents such as consent forms, protocols, and continuing reviews.

Assist with management of Investigational Products including arrival, storage, handling including requesting requisitions, inventory, and reordering

Ethical and Participant Safety Considerations- Maintain familiarity 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 Management and Informatics- Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. 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. Assist with the development of data collection documents; including data capture, storage, management, quality, and preparation for analysis.

Independently investigate incomplete, inaccurate, or missing data and documents to ensure accuracy and completeness of data; follow SOPs for data quality assurance. Run summaries and reports on existing data. Use required processes, policies, and systems to ensure data security and data provenance.

Recognize and report vulnerabilities related to security of physical and electronic data.

Scientific Concepts and Research Design- May conduct literature reviews under the direction of the CRC, CRC-RN, or PI. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.

Leadership and Professionalism- Encourage and support colleagues to complete project work. Assist research colleagues in identifying efficiencies and improving process. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements. May serve as mentor to other staff.

Study and Site Management- Participate in sponsor-required training. Maintain inventory and quality of study supplies and equipment. Prepare items for site initiation visits, and take part in visits as requested/directed. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms.

Communication and Team Science- 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. Write and speak clearly in a variety of settings and styles to convey messages and ideas effectively.

And other work as assigned.

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

Qualifications Required At This Level
Education/Training
Work requires an associate's degree.

Experience
One year of relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Skills
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Requisition Number
401261649

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
803 CLINICAL RESEARCH SPECIALIST, SR

Job Family Level
09

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

One year of relevant experience (e.g., research, clinical, interaction with study population, program coordination).

Auto req ID

89871BR

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.

PI97824662