Clinical Research Specialist

Location
North Carolina, United States
Posted
25 Oct 2018
End of advertisement period
25 Dec 2018
Ref
401444374
Contract Type
Permanent
Hours
Full Time

Job Description

Occupational Summary

Must speak and write Japanese fluently.

This position is part-time.


 The primary role of this position is to deliver and monitor daily the TICAA intervention for Japanese speaking participants. Supervisor: This position reports directly to the Research Practice Manager. As a research staff member in the School of Nursing (SON) CRU, this position is directly accountable to the SON's Research Practice Manager (RPM) for these specific responsibilities: a) appropriate human subjects and research training according to institutional standards; b) good clinical practice (including IRB submissions and renewals; protocol initiation; patient recruitment, screening, consent and enrollment; drug accountability; safety reporting; and study close-out); c) meeting the minimum qualifications and experience for the appropriate research staff role; d) adherence to CRU standard operating procedures, institutional HRPP and clinical trial billing policies, and all applicable regulatory requirements; and e) attendance at regular CRU meetings to debrief on CRU, institutional and departmental policies and procedures. The RPM will solicit input from the Principal Investigators and study teams on these items for the PEP.

Essential Duties

1. Recruitment and consent of research subjects a. Will be responsible for reviewing the screening health assessment and determine study eligibility. b. Interact with potential subjects as needed to resolve any questions prior to consent. c. Brainstorm with the PI about new ways to recruit and retain research participants d. Prioritize, coordinate and track contact with potential subjects as well as new and currently-enrolled study participants
2. Intervention Support a. Provide group and individual support for participants. b. Daily will monitor the implement of the intervention and track involvement.
3. Data Collection a. Participate in the development of study forms, questionnaire and study procedures (SOPs). b. Collect required study data which could include surveys via internet and by telephone. c. Ensure all data collected is captured, collected and stored in the approved IRB and Duke required practice. d. Keep and maintain detailed records of where each subject is in the study timeline, and relevant lost subject/withdrawn data when applicable. e. Provide enrollment counts to PI when requested, as well as counts for how many subjects have completed each time point in the study. f. Schedule (and re-schedule when necessary) and confirm appointments g. Prepare materials for each session.
4. Communication/Reports a. Provide requested information about enrolled subjects to PI and study staff and facilitators b. Alert PI to potential issues where it is not clear how to proceed (i.e., situations that are out of the ordinary) c. Assist collaborators and statisticians in understanding data discrepancies Check manuscripts and papers written using the data collected to ensure the figures reflect study records.
5. Organization a. Ensure that all study materials used are the ones approved by the IRB on the eIRB website. b. Assist the PIs in requesting new SED folders for new studies c. Assist PIs in proofing new study materials and suggesting modifications in wording or order, providing feedback based on previous contact with research subjects and materials 6. Database management a. Coordinate and assist with database data entry. a. Facilitate communication with database specialists to create tracking databases and survey databases for TICAA study. b. Maintain study databases and ensure they are up-to-date at all times. c. Assist with data coding, working closely with statisticians for data clean up and preparation for statistical analysis.
7. Miscellaneous a. Follow Duke procedures in regards to collecting IRB Data Disclosure form and requirements around SSN# storage and payment processing. b. Perform other related and requested duties incidental to the work described herein.

Preferences

Preferred RN or equivalent from another country. Experience delivering health-intervention programs to an Asian-American female population preferred.

Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requisition Number 401444374
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 PART 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

102271BR