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,