Clinical Specialist III /Clinical Research Coordinator

Job Description:

Work location address

Address: 4 W 4th Ave, San Mateo, CA 94402

Candidates must be in Houston, TX or San Francisco, CA the bay area.

Title – Clinical Research Coordinator

Number of Leased Workers needed – 1

Tentative start date – asap

Tentative end date – 12 months

Work shift (days/times) – 1st shift

Work Location – Remote, but candidate MUST go into the office 1 to 2 days a week. Candidates must be in Houston, TX or San Francisco, CA the bay area.

Travel Required (% of travel) – Travel to Caption Health offices in San Mateo and to downtown San Francisco. Travel is estimated to be 2 days a week in average

Is this a temp to perm position – pure contract

Job Overview:

The client's Ultrasound segment, a fast-growing business in HealthCare, is the global leader in ultrasound medical devices and solutions. The portfolio spans the continuum of care to enable customers with ultrasound screening, diagnosis, treatment and monitoring of diseases. Our customers are seeking to improve efficiency in radiology and beyond and increase user confidence to provide better clinical outcomes continues to grow. Consequently, the need for AI, digital solutions, and automation, connecting devices and software in one seamless ecosystem continues to proliferate.

Caption Health is a part of client's Healthcare and focuses on developing clinical applications that aid in early disease detection, using AI to assist in conducting ultrasound scans.

The Clinical Research Coordinator will be responsible for multiple administrative tasks related to the organization of multiple internal and external clinical client sponsored trials including IRB submissions, along with upkeep of clinical documentation as necessary.

Essential Responsibilities:

• Overseeing the smooth execution of internal research studies, including scheduling, recruitment, patient consent, and administering questionnaires.

• Manage IRB submissions and study progress for internal and external research studies and ensure that documentation and requirements are up to date.

• Appropriately maintain regulatory binders, subject binders and CTMS for research studies.

• Coordinate and organize clinical staff resources for internal research study execution.

• Assist the field Clinical Development team with administrative tasks for all clinical trials, including tracking study status and enrollment, managing research budgets, and maintaining up-to-date regulatory documents as required.

• Collecting and exporting data obtained from research studies for analysis by team.

• Assist in coordinating labeling efforts and panel reads by external physicians and sonographers.

• Ensure adherence to research regulatory, ethical and safety standards.

• Ensuring that the necessary supplies and equipment for a study are in stock and in working order.

• Occasional travel to clinical trial sites to provide assistance.

• Perform other duties as assigned.

Basic Qualifications:

• Bachelor's degree in a science or health-related field or equivalent education and experience.

• 3-5 years of experience in healthcare or clinical research is strongly desired.

• Understanding of ICH-GCP guidelines.

• CCRC certification is a plus.

• Highly detail-oriented.

• Exceptional interpersonal skills.

• Proven communication skills, both written and verbal.

• Excellent organizational skills.

• Proficiency in Microsoft Office applications

• Must be willing to travel as required (up to 10%).

• Working knowledge of clinical research operations and documentation.

• Proven ability to drive multiple projects and initiatives in a cross functional environment while leveraging key stakeholders and engaging end users.

Eligibility Requirements:

• This position is based in the United States only, in Houston or the Greater San Francisco Area. Legal authorization to work in the U.S. is required. client HealthCare may agree to sponsor an individual for an employment visa now or in the future if there is a shortage of individuals with particular skills.

• Must be willing to travel as required.

Desired Characteristics:

• Well organized and structured, high attention to detail.

• Ability to work independently and systematically.

• Knowledge of Quality Management Systems (QMS).