School of Medicine
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Clinical Research Specialist, Sr – Psychiatry – Goldston Team
Description of Responsibilities:
Responsibilities will include (but not necessarily be limited to):
- Participant outreach and scheduling of follow-up assessments
- Retention efforts including contact between scheduled assessments
- Yearly telephone assessments with research participants
- In-person assessments including neuropsychological testing, structured psychiatric/mental health assessments, and MRI screening and preparation
- Support for the "recovery " study to examine the effects of abstinence for one month on recovery of functioning, including traveling to participants' home to pick up samples
- Participation in weekly Duke NCANDA calls and monthly cross-site calls
- Assistance with documentation required for study, regulatory requirements, submission of data to the coordinating center
- Management of data in a central repository, troubleshooting data issues
- Assisting the CRC with managing some participant payments
- Post-participant-visit tasks, including required tracking, scoring neuropsychological data, entering and filing data, and sending participant necessary follow-up information including resources
Good candidates for this position will possess the following qualities:
- Enthusiasm for interacting with people, including participants, their families, and colleagues at Duke
- Good interpersonal skills and comfort discussing difficult topics with participants, including substance use, mental health and psychiatric disorders, and various personal life experiences
- Attention to detail in collecting and entering data, and research and retention protocols
- Flexibility – in work schedule and job duties
- Good collaborative skills in working with coworkers both at Duke and other sites in the study
- Good organizational and task management skills – necessary for managing the many various tasks of the position
Type of Research:
The person in this position will work as part of the Duke NCANDA-A (National Consortium on Alcohol and Neurodevelopment - Adolescence through Adulthood - http://www.ncanda.org) team as well as the multisite NCANDA-A team in coordination and implementation of the protocol. This research protocol includes imaging and collaboration with the Brian Imaging and Analysis Center (BIAC).
Operations:
Under supervision, prepares for study monitoring and audit visits. 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 subjects. Recruits research participants according to study protocol. 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. Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation. Schedules participants for research visits (excluding those requiring EHR access). Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. 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 in non-complex studies. These are typically repositories, survey studies, simple observational studies and non-patient studies that do not involve investigational products or devices. Cannot consent for any studies that involve investigational products or devices or require clinical research orders in Maestro Care (i.e., electronic health record).
Data:
Enters and collects basic data for research studies. May score scripted or validated tests and measures. With supervision, responds to queries created by a CRO or the data manager. May assists with quality control and data cleaning as directed. 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.
Science:
Demonstrates a basic understanding of the elements of research study designs.
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. For studies with simple supplies or equipment, ensures 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.). Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Description of Portfolio Responsibilities: (Effort .%):
40% Participant outreach, retention, and scheduling for annual assessments
40% In-person assessments including neuropsychological testing, structured psychiatric/mental health assessments, and MRI screening and preparation
20% Data entry, assessment scoring, data management and quality assurance
Minimum Qualifications
Education
Work requires an Associate's degree.
Experience
One year of relevant experience. A Bachelor's degree may substitute for 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.
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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.