Clinical Research Coordinator - Psychiatry - Behavioral Medicine Division - Peterchev Lab

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:

• 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.
• 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 study monitoring and audit visits under supervision.
• Maintains participant-level documentation for all studies, including complex ones (e.g., procedural and interventional studies) and/or those requiring 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 complex studies (e.g., procedural and interventional studies). May train or oversee others.
• Develops or helps develop SOPs. May train or oversee others.
• Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
• Maintains study-level documentation for all studies, including complex ones (e.g., procedural and interventional studies). May train or oversee others.
• Conducts and plans for complex study visits. May train staff.
• Participates in study team meetings.

Ethics:

• Recognizes known potential adverse events identified in the protocol or investigator brochure and reports to the study team.
• Conducts and documents consent for participants for all types of studies, including complex ones and/or those requiring any orders in Maestro Care. May train or oversee others.
• Develops consent plans and documents for participants in various studies. May train or oversee others.
• Develops and submits documentation and information for IRB review. Communicates with IRB staff and reviewers and handles issues appropriately. May train or oversee others.

Data:

• Enters and collects basic data for research studies. May score scripted or validated tests and measures.
• Ensures accuracy and completeness of data for all studies, including complex ones.
• Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures.
• Recognizes and reports security vulnerabilities of physical and electronic data.
• May develop or review RDSPs for multiple study protocols.
• Independently uses and implements technology to enhance productivity or processes. May train or oversee others.

Science:

• Assists with simple literature searches.
• Will be given opportunities to contribute to scientific publications.

Study and Site Management:

• 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.
• Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and maintaining current protocol information. May train others.
• Ensures ample supplies and that equipment is in good working order for studies with complex supplies or equipment. May forecast staffing needs. May train or oversee others.
• Ensures studies are conducted in compliance with institutional requirements and other policies.
• Follows protocol-specific systems and process flows.
• Prepares studies for closeout and document storage. May train or oversee others.

Leadership:

• Maintains Duke and project-specific training requirements.
• Keeps current with research updates by attending key external departmental meetings (e.g., Research Wednesday, RPN, additional training).
• Navigates processes and people involved in Duke clinical research, demonstrating organizational awareness and interpersonal skills necessary to get work done efficiently.
• Demonstrates resilience and adaptability to change.
• Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Clinical Responsibilities:

• Works with participants with anxiety, depression, or other psychiatric or medical conditions as part of various research studies.
• Learns how to conduct clinical diagnostic interviews and becomes independent in interviewing research participants regarding their mental health profile.
• Develops basic skills in assessing and reducing distress for participants as part of research sessions.
• Administers simple screening instruments for neurological and psychiatric disorders as part of study participant inclusion/exclusion assessment.

Type of Research:

• Multiple studies utilizing Non-Significant Risk devices (not IDE studies, no FDA oversight) that administer noninvasive transcranial magnetic stimulation (TMS) to healthy research participants for evaluation of novel technology and treat participants with TMS for off-label use.

Special Skills:

• Learns how to operate neurostimulation and related neuronavigation equipment independently. Training and ample supervision will be provided before operating the equipment independently.
• Learns about equipment maintenance and simple troubleshooting after appropriate training.
• Manages billing for the Duke Brain Stimulation Center and represents the Center during various presentations and events.
• Involved in recruitment and retention of participants as well as participant management throughout various studies.

Required Qualifications at this Level:

• Education/Training: Completion of a Bachelor’s degree.
• Skills:
  • Proficient in using computing software and web-based applications (e.g., Microsoft Office products and internet browsers).
  • Ability to hold a 3kg (approximately 6.5lbs) TMS coil in position for extended periods.
  • Strong interest or background in engineering is a plus.
  • Strong interpersonal skills.

Additional Information:

• The intent of this job description is to provide a representative level of the types of duties and responsibilities required of positions given this title and shall not be construed as a declaration of the total specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities 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.

Minimum Qualifications

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities 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.

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $58,656.00 to USD $98,000.00. Duke University considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, and key 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 and dental 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/

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: 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 of 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.