Clinical Research Associate II (Field CRA) (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Remote US home office; priority is given to candidates residing in Chicago, Dallas, Austin, or Houston, Texas. The role requires onsite and remote work, including approximately 30–60% travel to research laboratories, hospitals, conferences, and affiliated facilities.
Annual base salary: $89,000–$130,000 for a mid-cost labor market; the range may vary by region.
Company
is a global healthcare company that designs, develops, manufactures, and markets innovative medical products for challenging medical conditions.
What you will do
- Manage clinical study sites, ensuring timely data entry, query resolution, data quality, and audit readiness.
- Conduct site qualification, initiation, routine monitoring, and closeout activities both remotely and onsite.
- Monitor protocol compliance, safety reporting, regulatory adherence, and investigator-site training.
- Manage device accountability, inventory, distribution, and complaint or malfunction tracking.
- Maintain regulatory documentation, trial master files, study timelines, reports, and study-related materials.
- Support clinical infrastructure, quality procedures, informed consent development, and mentoring of junior clinical staff.
Requirements
- Bachelor’s degree in biological sciences or a health-related field, with 3+ years of relevant clinical, scientific, nursing, medical device, or pharmaceutical experience and at least 1 year of clinical monitoring experience.
- Working knowledge of medical terminology.
- Strong verbal, written, interpersonal, organizational, and problem-solving skills with close attention to detail.
- Intermediate proficiency in Word, Excel, PowerPoint, or equivalent software.
- Ability to manage multiple projects, work collaboratively, provide guidance to junior staff, and follow applicable quality, regulatory, security, and privacy requirements.
- Ability to work in general office, laboratory, and hospital environments, travel approximately 30–60%, and work onsite and remotely.
Nice to have
- Familiarity with laws, regulations, standards, and guidance governing clinical studies.
Culture & Benefits
- Collaborative environment with continuous learning and performance recognition.
- Medical, dental, vision, life, AD&D, short- and long-term disability insurance for eligible employees.
- 401(k) plan with employer match.
- Paid parental leave, company holidays, accrued vacation, and paid sick time.
- Competitive compensation package with equity opportunities when applicable.
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