Clinical Research Specialist

The Jackson Laboratory•Farmington, CT

About The Position

Under the supervision of the Director, Clinical & Translational Research Support (DCTRS), the Clinical Research Specialist supports investigators at The Jackson Laboratory and their clinical collaborators by contributing clinical site and regulatory expertise to grant proposal development and clinical protocol design, development, and implementation. The role helps expand JAX’s clinical research portfolio and ensures clinical studies are designed and conducted in accordance with established policies, procedures, regulations, and good clinical practices (GCP).

Requirements

  • Master’s degree in health sciences or a relevant scientific area, such as epidemiology, clinical research administration, public health, or biology.
  • At least three years of experience in patient-facing clinical research (study coordination) in an academic or other clinical setting.
  • Knowledge and experience in clinical study design, statistical analysis, protocol development, the informed consent process and regulations, CRF development, and IRB regulations and requirements.
  • Excellent written and oral communication skills and ability to work with multidisciplinary collaborators.
  • Ability to manage multiple activities simultaneously and effectively prioritize tasks and responsibilities.
  • Strong organizational and problem-solving skills.
  • Strong interpersonal skills.
  • Strong commitment to customer service.

Responsibilities

  • Support JAX faculty and collaborators in developing internal and external clinical research funding proposals, including study design, human-subject protection components, and clinical study protocols for funded grants.
  • Participate in clinical site management, including identifying and qualifying clinical sites, preparing initial IRB submission materials and recruitment plans, and providing ongoing problem-solving and support to clinical sites.
  • Develop and maintain JAX clinical research Standard Operating Procedures.
  • Contribute clinical research operations expertise to project development.
  • Collaborate with DCTRS and the JAX IRB to develop and deliver educational programs for investigators and key study personnel on federal regulations and JAX policies and procedures.
  • Facilitate collaborative research between JAX investigators and clinical site investigators and staff by leading clinical protocol and supporting-document development and advancing projects through IRB submission.
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