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

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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