• , US

Company:  Confidential

Job Title: Sr./Clinical Research Associate II (Unblinded)

Job Number: 79108

Location: , US

Job Description

The Clinical Research Associate supports clinical studies for product approvals and market adoption. Collaborating with cross-functional teams and vendors, they ensure trial success and quality results. They assist in establishing practices for future growth.

Responsibilities

* Develop and maintain investigator relationships, ensuring protocol adherence and ICH-GCP compliance. * Facilitate scientific discussions on product and protocol requirements. * Monitor and resolve vendor issues, drive timelines, and train site staff. * Conduct site visits, administer training, and ensure data accuracy and compliance. * Manage device/medication accountability and regulatory submissions. * Protect subject rights, ensure data accuracy, and perform source data verification. * Communicate project updates and maintain compliance with regulations and company policies. * Demonstrate flexibility and initiative in completing assigned tasks.

Required Skills

* Bachelor’s degree in a science field, Nursing degree preferred. * 3+ years of clinical trial monitoring experience, biotech/pharma background preferred. * Proficient in GCP, ICH guidelines, Microsoft Office. * Familiarity with clinical trial systems and terminology. * Strong organizational, problem-solving, time management skills. * Track record in dynamic environments, ability to lead projects and collaborate effectively. * Excellent communication skills, ethical standards. * Up to 25-50% travel required.

Application Deadline: 2024-07-08

 

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