CLINICAL RESEARCH COORDINATOR

Participates in or leads day to day operations of clinical research studies conducted by Principal Investigator(s) (PI) at Duke Health; performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Operations:

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Follows SOPs and strategies to manage and retain research participants. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Develops or helps develop SOPs. May train or oversee others. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. Conducts activities for study visits in compliance with the protocol. May train staff. Participates in study team meetings.

Ethics:

Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others. Assists with the development of consent plans and documents for participants. Develops and submits documentation for IRB review in iRIS. Communicates with the IRB staff and reviewers and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:

Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Independently corrects and documents incomplete, inaccurate or missing data for non-complex studies. Follows SOPs for quality assurance. Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. Follows requirements for depositing data into an appropriate repository and meta-data specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing. Learns and uses new technology when required.

Science:

Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scientific publications or presentations. Serves as an author on poster presentations or publications.

Study and Site Management:

As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Uses OnCore and eREG systems and system reports to manage research protocols. May train or oversee others. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others. As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).

Leadership:

Maintains Duke and project specific training requirements. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

* Type of Research:

Population: Pediatric GI (subjects undergoing endoscopy/colonoscopy).

Study Scope:

Multi-site biorepository (R01). Management: Responsible for screening, recruitment, obtaining informed consent in the pediatric population, obtaining samples from procedures mentioned above, collaboration with BRPC, data collection/entry, possible regulatory oversight.

Anticipated Pay Range:

Duke Universityprovides an annual base salary range for this position as USD $59,829.00 to USD $99,960.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, andkey skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical anddental care programs, generous retirement benefits, and a wide array of family- friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Completion of an Associate's degree

Work requires a minimum of two years of relevant research experience. Completion of theDOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor's degree may substitute for 2 years required experience.

Work requires a minimum of two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor's degree may substitute for 2 years required experience.