Psychiatry - Clinical Research Specialist, Sr - Child Division - Posner Lab

Duke University

1mo ago

Job
Full-time
Junior Level
Research & Development
Healthcare
Durham

AI generated summary

You need an Associate's degree (or Bachelor's), one year of relevant experience, Spanish speaking skills, a driver's license, and prior phlebotomy experience or willingness to train.
You will manage study documentation, recruit participants, conduct visits, ensure data quality, support IRB submissions, assist in research team meetings, and maintain compliance with protocols.

Requirements

Work requires an Associate's degree.
One year of relevant experience. A Bachelor's degree may substitute for required experience.
Spanish speaking, drivers license required, prior phlebotomy experience or willing to be trained.

Responsibilities

Assists with study level documentation and approvals for international studies. 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.
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). 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.
Enters and collects basic data for research studies. 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. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Knowledgable about requirements for depositing data and following 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. Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating reports on study progress for the PI and other study team members and collaborators.
May assist with simple literature searches under supervision from PI or CRC. 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.
As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system. Records basic protocol information in clinical research management system. Ensure that studies are conducted in compliance with institutional requirements and other policies. 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).
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. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

FAQs

What is the job title for this position?

The job title is Psychiatry - Clinical Research Specialist, Sr - Child Division - Posner Lab.

What educational qualifications are required for this position?

An Associate's degree is required, with a Bachelor's degree serving as a substitute for required experience.

How much relevant experience is required for this role?

One year of relevant experience is required for this position.

Are there any special skills required for this job?

Yes, special skills include being Spanish speaking, possessing a driver’s license, and having prior phlebotomy experience or a willingness to be trained.

What type of research will the Clinical Research Specialist be involved in?

The research will focus on recruiting pregnant participants and their newborns for observational inter-generational studies.

What does the anticipated pay range for this position look like?

The anticipated pay range is USD $20.35 to USD $30.82 per hour.

Does Duke University promote diversity and inclusion in its hiring practices?

Yes, Duke University is committed to affirmative action and equal opportunity, valuing collaboration, innovation, creativity, and belonging in its community.

What physical job functions might this role entail?

Certain essential job functions may require specific physical and/or mental abilities, with additional information available from the hiring department.

Is there an opportunity for participation in scientific publications or presentations?

Yes, the role may involve contributing to the development of scientific publications or presentations and serving as an author on poster presentations or publications.

What are the expected responsibilities regarding ethics in the role?

The responsibilities include recognizing potential adverse events, conducting and documenting participant consent for non-complex studies, and assisting with IRB documentation submissions.

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Duke University is a leading academic institution dedicated to excellence in education, research, and community service. Their ultimate mission is to advance knowledge and develop leaders who can make a positive impact on society. Duke University aims to provide a transformative educational experience, fostering intellectual growth, critical thinking, and ethical leadership. By integrating rigorous academics with a commitment to social responsibility, Duke seeks to contribute to the global community and address pressing challenges through innovation and collaboration.