Duke University
CLINICAL RESEARCH SPECIALIST, SR
Duke University, Durham, North Carolina, United States, 27703
CLINICAL RESEARCH SPECIALIST, SR
role at
Duke University
1 day ago. Be among the first 25 applicants.
Operations Under supervision, assists with managing investigational products (IP) including arrival, storage and handling (requisitions, inventory, and reordering). Prepares for study monitoring and audit visits. Documents participant-level information for non-complex studies. Follows SOPs and manages research participants. Recruits and screens participants either in person or over the phone. Employs simple procedures for collecting, preparing, processing, shipping and maintaining specimen inventory. Assists with study documentation, scheduling, and preparation of documents, equipment and supplies. Conducts and documents non-complex visits and scripted testing or interviews. Manages participant payment and participates in study team meetings.
Ethics Recognizes known potential adverse events and reports to study team. Conducts and documents consent for participants in non-complex or minimal risk studies. Assists with development of consent plans and documents. For non-complex studies, develops and submits documentation for IRB review.
Data Enters and collects basic data. Scores scripted or validated tests and measures. Corrects incomplete, inaccurate or missing data. Runs data summaries and reports. Ensures data security and compliance with repository and metadata specifications. Assists with merging datasets, recoding variables, and creating tables and visualizations. Updates and develops reports on study progress.
Science Assists with simple literature searches. Develops elements of research protocols for simple studies. Contributes to scientific publications or presentations.
Study and Site Management Attends or schedules site visits. Records participant accrual and consent documentation. Records basic protocol information. Ensures supplies and equipment are available and functional. Prepares studies for closeout.
Leadership Works with manager to identify opportunities and develop training plan. Attends training courses and trains others. Attends departmental meetings and communicates with study personnel.
Education Associate degree required.
Experience One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of experience.
Degrees, Licensures, Certifications One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of experience.
Equal Opportunity Statement Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military 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.
Seniority level Mid-Senior level
Employment type Internship
Job function Health Care Provider
Industries Higher Education
#J-18808-Ljbffr
role at
Duke University
1 day ago. Be among the first 25 applicants.
Operations Under supervision, assists with managing investigational products (IP) including arrival, storage and handling (requisitions, inventory, and reordering). Prepares for study monitoring and audit visits. Documents participant-level information for non-complex studies. Follows SOPs and manages research participants. Recruits and screens participants either in person or over the phone. Employs simple procedures for collecting, preparing, processing, shipping and maintaining specimen inventory. Assists with study documentation, scheduling, and preparation of documents, equipment and supplies. Conducts and documents non-complex visits and scripted testing or interviews. Manages participant payment and participates in study team meetings.
Ethics Recognizes known potential adverse events and reports to study team. Conducts and documents consent for participants in non-complex or minimal risk studies. Assists with development of consent plans and documents. For non-complex studies, develops and submits documentation for IRB review.
Data Enters and collects basic data. Scores scripted or validated tests and measures. Corrects incomplete, inaccurate or missing data. Runs data summaries and reports. Ensures data security and compliance with repository and metadata specifications. Assists with merging datasets, recoding variables, and creating tables and visualizations. Updates and develops reports on study progress.
Science Assists with simple literature searches. Develops elements of research protocols for simple studies. Contributes to scientific publications or presentations.
Study and Site Management Attends or schedules site visits. Records participant accrual and consent documentation. Records basic protocol information. Ensures supplies and equipment are available and functional. Prepares studies for closeout.
Leadership Works with manager to identify opportunities and develop training plan. Attends training courses and trains others. Attends departmental meetings and communicates with study personnel.
Education Associate degree required.
Experience One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of experience.
Degrees, Licensures, Certifications One year of relevant experience. Completion of the DOCR North Carolina state approved Clinical Research Pre Apprenticeship program may substitute for one year of experience.
Equal Opportunity Statement Duke is an 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 (including pregnancy and pregnancy related conditions), sexual orientation or military 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.
Seniority level Mid-Senior level
Employment type Internship
Job function Health Care Provider
Industries Higher Education
#J-18808-Ljbffr