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)