Sr. Clinical Research Associate Job at Custom Search Inc., Saint Paul, MN

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  • Custom Search Inc.
  • Saint Paul, MN

Job Description

Our small start-up client is adding (Sr.) Clinical Research Associates (CRA) to the team. The CRA works as part of the clinical team to ensure the completion of company-sponsored clinical studies. As an internal and externally facing position, this position interacts directly with the internal study team, clinical vendors, clinical Investigators, and other study staff at a clinical research site. The CRA will be the primary contact for the study sites regarding the proper execution of the clinical study.

Your role with the company:

  • May provide study support for one or more clinical studies
  • Execute specific aspects of the clinical study as directed by the CPM and clinical affairs leadership
  • Support the investigator and investigational site selection process
  • Manage the clinical sites within the approved protocol and operating plans
  • Support the development of study operating plans
  • Responsible for site readiness
  • Collaborate with the clinical field team to support adequate enrollment at clinical sites
  • Support the ongoing communication with clinical vendors such as CROs, core labs, or others as designated
  • Support the development of clinical study documents such as protocols, CRFs, training materials, informed consent, operational plans, and required forms
  • Support and or perform remote and/or on-site qualification, initiation, interim, and closeout monitoring visits
  • Responsible for the collection of source documents and associated materials to facility proper safety oversight
  • Support for preparation of materials for independent oversight committees (such as DMC or CEC)
  • On-going review of study data through electronic data capture
  • Tracking and report out of clinical site metrics
  • Identification and escalation of potential patient safety concerns, compliance issues, and other study risks
  • Support ensuring the audit-readiness of the study throughout the study duration

Desired Profile:

  • Bachelor’s degree in life sciences, biological sciences, pharmacy, nursing, biomedical engineering or related field
  • Minimum 2 years clinical research experience in the medical device industry
  • Experience with pre-market IDE clinical trials (Feasibility and Pivotal preferred)
  • Neuromodulation experience preferred
  • Knowledge of good clinical practices, ICH, HIPAA, and other applicable clinical trial-related regulations
  • Familiarity with medical terminology
  • Ability to work both independently and as part of a team
  • Strong communication, interpersonal, and problem-solving skills
  • Excellent organizational and time management skills
  • Proven ability to work in a fast-paced environment
Ability to travel up to 35% primarily within US (average 2x/month)

Job Tags

Remote job, Interim role,

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