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CLINICAL RESEARCH SPECIALIST, SR

Job description


diversity employer



CLINICAL RESEARCH SPECIALIST, SR
CTSI-Clinical & Translational Sci Awards

Operations: Screen participants for minimal risk studies. May screen participants for studies with greater than minimal risk, under supervision. Maintain subject level documentation for minimal risk studies, or for other studies under direction. Schedule participants and conduct visits for minimal risk studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. 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. 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 minimal risk studies. May conduct consent for studies with greater than minimal risk, under the supervision of a CRC or CRNC. Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision. Provide input for DUHS IRB documents such as consent forms, protocols, and continuing reviews.

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 thatthe safety of research participants is a priority. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial Data: Map protocol data flow. Predict areas of vulnerability for a protocol's data flow plan. Determine areas where data provenance may be compromised. 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 Assist with development of and follow SOPs for data quality assurance.

Science: Conduct literature reviews under the direction of the CRC, CRNC, or PI. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims.

Leadership: Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. May serve as mentor to other staff. 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: Collect information to determine appropriate feasibility, recruitment and retention strategies. Ensure participant care expenses have appropriate financial routing in a timely manner. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. and participate in budget development as appropriate. Assist with study budgets. 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. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Prepare for closeout and document storage 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.

Type of Research: This candidate will be working in the Primary Care Research Consortium with study populations that range from pediatrics to geriatrics. PCRC study complexity is typically limited and more pragmatic than complex. The candidate will work under the regular supervision of the Primary Care Investigator and CRCs.

Special Skills: Strong verbal and written communication skills required. Familiarity with Duke systems preferable but not required. Microsoft Office skills (Outlook, Word, Excel, PowerPoint) are necessary; additional skills in database management and electronic data capture systems (e.g., Access, Redcap) are preferred but not required.

Bilingual strongly preferred.

Ability to work variable shifts during the week (e.g., M/W/F 8am-5pm, T/TH 10am-7pm or 11am-8pm or vice versa (with one hour for lunch)) required. Work hours are typically 8am-5pm with a 1 hour lunch. However, some flexibility to work before clinic (7:00 or 7:30 am), at lunchtime, or at the end of the work day (past 5:00 pm) may be needed for study-related meetings with practice providers and staff. Travel to community clinics for participant enrollment and followup is required and mileage is reimbursed according to guidelines. Travel out of town (weekdays and/or weekends) may be required based on specific study needs (for training and updates).

Requisition Number
401378741

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, 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

Work requires an associates degree.

Experience

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

Auto req ID

97292BR

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.

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Job No:
Posted: 2/28/2018
Application Due: 4/4/2018
Work Type:
Salary: