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Sr. Clinical Research Specialist - Center for Aging

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Duke University

4d ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Durham

AI generated summary

  • You need an Associate's degree and one year of relevant experience (Bachelor's can substitute). Familiarity with Microsoft Office and web applications is essential.
  • You will manage participant documentation, recruit subjects, conduct visits, collect data, maintain study records, and assist with protocols and reporting under supervision.

Requirements

  • Work requires an Associate's degree.
  • One year of relevant experience. A Bachelor's degree may substitute for required experience.
  • Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Responsibilities

  • Performs a variety of research, data, and clerical duties of a routine and technical nature to support the conduct of clinical research under the supervision of a Clinical Research Coordinator or similar Clinical Research Units (CRU), Oversight Organization (OO) designee. Participates in day-to-day operations related to the collection, compilation, and documentation of clinical research data, and may train Clinical Research Specialists (CRS) in these tasks.
  • Maintains participant level documentation for non-complex studies (e.g., questionnaires, data registry, scripted) outside of the EHR.
  • Recruits research participants according to study protocol and follows standard operating procedures (SOPs) and strategies to manage and retain research subjects.
  • Screens participants in person or over the phone for non-complex studies, or may collect information from the electronic health record to assist study team in determining eligibility.
  • Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.
  • Assists with maintaining and establishing study level documentation.
  • Schedules participants for research visits. 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.
  • Follows SOPs and 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, may develop and submit documentation and information for IRB review.
  • Enters and collects basic data for research studies. May score scripted or validated tests and measures.
  • Assists with quality control and data cleaning as directed.
  • Independently responds to queries created by a CRO or the data manager.
  • Independently corrects and documents incomplete, inaccurate, or missing data for non-complex studies and 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.
  • Documents and maintains documentation to facilitate data sharing during publication or study closeout.
  • For non-complex protocols, identifies when various data standards should be used in creating eCRFs and EDCs and integrates as according to best practices. Knowledgeable about the use of data standard policies.
  • 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 and may develop reports on study progress for the PI and other study team members and collaborators.
  • Under supervision, executes testing process after the completion of a build, or following any project changes or system upgrades and may conduct some testing and documentation for Part 11 projects.
  • Assists with simple literature searches.
  • Under guidance, may develop elements of research protocols for simple studies (e.g., registries, survey studies).
  • Provides some contribution to scientific publications or presentations (no authorship).
  • As directed, attends or schedules site visits and assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
  • Records participant accrual information and consent documentation for non-complex studies, and basic protocol information 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.
  • 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.).
  • Communicates with other study personnel as required for study implementation and routine problem resolution.

FAQs

What is the job title for this position?

The job title is Sr. Clinical Research Specialist - Center for Aging.

Is this position grant funded?

Yes, this position is grant funded.

What institution is offering this position?

This position is offered by Duke University School of Medicine.

What is the primary focus of the Black Men’s Brain Health (BMBH) Project?

The BMBH Project focuses on increasing the engagement of Black/African American men in cognitive aging and dementia research, cultivating a culturally competent workforce, and investigating ethnocultural disparities in dementia.

What are the preferred skills for candidates applying for this role?

The ideal candidate should possess excellent verbal and written communication skills, demonstrate planning and organizational abilities, be flexible in achieving project goals, and show a willingness to acquire new skills.

What types of duties are included in the research operations responsibilities?

Research operations include maintaining participant documentation, recruiting and screening participants, scheduling research visits, and assisting with study-level documentation.

What qualifications are required for this position?

An Associate's degree is required, along with one year of relevant experience. A Bachelor's degree may substitute for the required experience.

Are there specific software skills needed for applicants?

Yes, applicants should have proficiency in using computing software and web-based applications, including Microsoft Office products and internet browsers.

Will the chosen candidate be expected to train others?

Yes, the chosen candidate may train others in the skills learned and assist in the development of team training plans.

What are the essential physical job functions outlined for this role?

The essential physical job functions will vary by department and may require specific physical and/or mental abilities. Details and reasonable accommodation requests will be provided by the hiring department.

Is Duke University committed to diversity and inclusion in its hiring process?

Yes, Duke University is committed to providing employment opportunities without regard to an individual's characteristics and aims to create a community built on collaboration, innovation, creativity, and belonging.

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Duke University

Fueled by creativity, informed by scholarship

Education
Industry
1-10
Employees
1924
Founded Year

Mission & Purpose

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.