Careers

Senior Manager, CARRA Registry Operations

Status: Exempt

Location: Position is remote

Reports to: Senior Director, Research

The CARRA Registry is the largest ongoing, observational registry in North America that collects clinical and patient-reported information about children and young adults with pediatric-onset rheumatic diseases. The CARRA Registry also serves as a biosample repository for select translational studies that leverage data collected through the Registry.

The CARRA Registry aims to understand the long-term outcomes and the long- and short-term safety and effectiveness of the medications used to treat pediatric rheumatic diseases. We aim to make it possible for all affected children and families to have the opportunity to participate in meaningful and high-quality clinical and translational research.

General Summary

The Senior Manager will serve as the daily point of contact for the CARRA Registry and Biorepository, associated research projects, and its vendors, including the academic research institution that currently serves as the coordinating center. This individual is expected to have experience in clinical research operations and apply those skills to positively influence the day-to-day operations of the CARRA Registry and Biorepository. The Senior Manager must be able to bridge gaps between CARRA members and leadership, related vendors, and other key stakeholders.

The ideal candidate will have knowledge of Good Clinical Practice guidelines and regulations governing research, data, and health information, and will also demonstrate a strong understanding of project management.

Position Responsibilities (Minimum of 37.5 hours/week)

  • Manage the CARRA Registry and Biobank daily operations, its key vendors and implementation of research initiatives, studies and related programs. This work includes but is not limited to:
    • Serve as the day-to-day staff contact for Registry and Biobank to ensure contractual obligations and performance expectations are met for internally and externally sponsored studies.
    • Assure Registry and Biorepository vendors are following federal regulations, best practice guidelines and policies applicable to operations.
      • Manage timelines, metrics, and standard operating processes
      • Participate in selection of external vendors when necessary and develop vendor specifications.
    • Coordinate the yearly CARRA Registry Retreat and yearly leadership meetings.
    • Develop reports and presentations highlighting successes and impact for marketing and development use
    • Ensure operational guidelines, SOPs and policies related to Registry and Biorepository operations and its vendors are not only up to date, but relevant and policies are in line with other CARRA internal programs utilizing data or biosamples from the CARRA Registry.
    • Ensure successful launch of all CARRA Registry substudies and other research programs
      • Manage and track substudy progress, problem solve, and develop associated procedures
  • Closely assist CARRA’s Associate Director, Research, with all planning, coordination, and implementation of initiatives and activities related to Registry and Biobank visioning and potential transition to an updated operational model.
    • Coordinate meetings, develop agendas, disseminate minutes, and conduct your own administrative responsibilities.
    • Other duties as assigned.

Amount of Travel Required

Less than 10 days per year

Education/Experience Required

Bachelor’s degree in a life-sciences related field, registered nurse certification or equivalent.

  • Past registry operations experience a plus
  • 5 years of experience in clinical research project management.
  • High proficiency in using electronic data capture systems (EDC)
  • Excellent communication and interpersonal skills to effectively interact with physicians, study coordinators, and other healthcare professionals
  • Ability to multi-task and deal with shifting priorities
  • Detail-oriented with strong organizational skills to manage multiple tasks and deadlines
  • Strong organizational, analytic and problem-solving skills.
  • Excellent interpersonal, verbal and, written communication skills
  • Self-directed ability to initiate and follow through on projects and tasks.
  • Ability to work across teams, departments and functions, providing project guidance and direction to
    colleagues and peers.
  • Experience with full Microsoft applications and proficiency
  • A self-starter able to independently but comfortable working in a team environment.

Compensation

Salary for this position is competitive and depends on experience. In addition, a comprehensive benefits package is included.

Location

Position is remote.

How to Apply

Please email curriculum vitae and cover letter to [email protected]. Applicant review will continue until the position is filled.