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CLINICAL RESEARCH COORDINATOR

Requisition Number::  144872
Date:  Oct 10, 2021
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

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. 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 all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others. Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for both minimal risk and complex studies (e.g., procedural and interventional studies). May train or oversee others, and work in a team environment while maintaining relationships with clinical staff. Follows SOPs. Assists with establishing and maintaining study level documentation. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings.

 

This position will primarily be responsible for the screening, recruitment, and retention of patients for minimal risk studies, assisting with IRB submissions and amendments, conducting qualitative interviews, and the development of standard operating procedures (SOPs). This person will also be responsible for study level documentation and the management of study participants in Duke’s clinical research management system, OnCore.



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. Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data
Enters and collects basic data for research studies. Will collect and organize qualitative data, and assist with qualitative analysis. May score scripted or validated tests and measures. 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. Learns and uses new technology when required.

 

This position will be responsible for data collection via patient-report and Duke’s electronic medical record. This position will also be involved in projects that utilize qualitative research methods and analysis.


Science
May assist with simple literature searches under supervision from PI or CRC. Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship).

Study and Site Management
As directed, attends or schedules site visits. Uses clinical research management system and its reports to manage research participants' activities, including minimum footprint, calendars, tracking/marking financial milestones, and all aspects of study visits. May train others. For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order. Follows protocol-specific systems and process flows. 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.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.


Type of Research:
This position will be involved in a variety of health services research and implementation science projects within the Department of Population Health Sciences. This position will be on projects that require qualitative research experience (i.e. conducting qualitative interviews and analysis), and screening, recruitment and retention of participants for minimal risk studies. The position will also involve some IRB and regulatory work.



Special skills:
Patient screening and enrollment experience; qualitative research methods experience would be preferred, but not a requirement; patient management in the EHR; IRB/regulatory experience

Minimum Qualifications

 

 

Education

Completion of an Associate's degree

 

Experience

 

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.

 

Duke 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 essentialjob 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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh