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(2) Sr. Clinical Research Associate
Custom Search, Saint Paul, Minnesota, United States, 55130
Our small start-up client is adding 2 (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)
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)