Durham, NC, US, 27710

Duke University’s School of Medicine - Department of Dermatology has an immediate need for a Clinical Research Coordinator located in Durham, N.C. More information about this department is located at the following link:

 https://dermatology.duke.edu/research

Occupational Summary

This position will work in a small team of coordinators in the Dermatology Research Unit on both Principal Investigator (PI) initiated and Industry funded studies of all phases for adult subjects.

The ideal candidate will have experience with clinical research and possess basic phlebotomy skills or be willing to learn with training.  The candidate may train or oversee others in all policies and procedures.

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 all policies and processes.

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.

Prepares for, provides support for study monitoring, and audit visits, including support for the reviewer. Addresses and corrects findings. 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.

Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues.  

Screens participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Conducts and plans for complex study visits. May train staff. Participates in study team meetings.

 

Ethics:
 

Identifies all adverse events (AE), and determines whether they are reportable.  Collaborates with the PI to determine AE attributes, including relatedness to study.

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. Develops consent plans and documents for participants in a variety of studies.

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. Ensures accuracy and completeness of data for all studies, including those that are complex in nature.

Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance.

In addition, recognizes and reports security of physical and electronic data vulnerabilities. Independently uses and implements technology to enhance productivity or process.

Study and Site Management:
 

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits.

Uses required EMR functionalities to manage participants and study visits.  May train others. Records basic protocol information in clinical research management system. For studies with complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast staffing needs.

Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol-specific systems and documents including process flows. Prepares studies for closeout and document storage.

Leadership:
 

Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned.

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.


 

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.