Senior Clinical Research Associate - Florida, GA, NY, Penn, Washington DC

New York, New York, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Robotics, HealthcareIndustries

Requirements

Candidates must possess a Bachelor's degree in life sciences, nursing, or a related field, or an equivalent combination of education and experience. A minimum of 5 years of experience in medical device clinical research is required.

Responsibilities

The Senior Clinical Research Associate will lead and manage all aspects of assigned clinical trials, including site selection, initiation, monitoring, and close-out. Responsibilities include developing study plans and budgets, coordinating with cross-functional teams, managing site contracts and budgets, and serving as a point of contact for clinical sites. The role involves conducting site visits to ensure compliance with protocols and regulations, monitoring patient enrollment and data collection, identifying and resolving site performance issues, and ensuring adherence to FDA regulations and ISO standards. Additionally, the Sr. CRA will assist with regulatory submissions, maintain the Trial Master File, oversee data integrity, manage risks, and participate in SOP development.

Skills

Clinical Trial Management

Site Management

Regulatory Compliance

Informed Consent Form Development

Study Budget Negotiation

Clinical Study Execution

Cross-functional Team Collaboration

Surgical Robotics

PROCEPT BioRobotics

Develops robotic solutions for BPH treatment

About PROCEPT BioRobotics

PROCEPT BioRobotics develops robotic solutions specifically for treating benign prostatic hyperplasia (BPH), a condition that affects many older men by causing prostate enlargement and urinary issues. Their main product, the AquaBeam Robotic System, utilizes Aquablation therapy, which combines real-time imaging, robotics, and waterjet technology to precisely remove prostate tissue in a minimally invasive manner. This system is designed for urologists and healthcare facilities, focusing on enhancing patient outcomes and making surgical procedures more efficient. Unlike competitors, PROCEPT BioRobotics emphasizes predictable results and reduced complications, which has led to their technology being recognized in clinical guidelines. The company's goal is to improve the quality of life for patients suffering from BPH through advanced surgical solutions.

Redwood City, CaliforniaHeadquarters

2009Year Founded

$319.1MTotal Funding

IPOCompany Stage

Robotics & Automation, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

401(k) Company Match

401(k) Retirement Plan

Paid Vacation

Paid Parental Leave

Paid Holidays

Wellness Program

Gym Membership

Risks

Competition from Intuitive Surgical and Medtronic may impact market share.

$175 million public stock offering could lead to shareholder dilution.

Reliance on AquaBeam System makes company vulnerable to technological failures.

Differentiation

AquaBeam Robotic System offers image-guided, minimally invasive urologic surgery.

Aquablation therapy provides effective outcomes regardless of prostate size or surgeon experience.

PROCEPT has over 100 peer-reviewed publications supporting Aquablation therapy's benefits.

Upsides

Increasing adoption of robotic-assisted surgeries boosts demand for AquaBeam System.

Global urology devices market projected to grow at 6.9% CAGR until 2030.

FDA's supportive regulatory environment favors innovative medical technologies like PROCEPT's.

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