Job Description

Clinical Research Coordinator

Company: ORCA

Location: Cocoa Beach, FL (Travel to other US locations may be required)

About ORCA:

ORCA (Outpatient Research Cardiovascular Alliance) is transforming cardiovascular clinical research. As a leading site management organization, we partner closely with clinical sites and medical device innovators to streamline every stage of the research process from expedited contract negotiations and site qualification to rapid patient screening, enrollment, and follow-up. Our accelerated approach significantly reduces the timeline from site selection to first patient enrollment, ensuring groundbreaking cardiovascular treatments reach patients faster. At ORCA, we're committed to advancing cardiovascular care by removing barriers and optimizing research excellence.

Position Overview:

As a Clinical Research Coordinator with ORCA, you will support clinical research sites in all aspects of conducting clinical trials. This includes consenting patients, data collection, management of study documentation, and effective communication with sponsors. The position is remote but requires substantial travel (up to 75%) to clinical research sites. Ideal candidates will possess strong experience as site-level CRCs, with experience running IDE clinical trials.

Key Responsibilities:

• Obtain informed consent from clinical trial participants and manage patient interactions.
• Collect and accurately enter patient data into electronic data capture systems.
• Manage and maintain all site-level clinical trial documentation, ensuring accuracy and regulatory compliance.
• Communicate and collaborate effectively with clinical site teams, sponsors, and CROs.
• Coordinate scheduling of patient visits and conduct patient follow-ups as necessary.
• Ensure compliance with regulatory requirements, protocol adherence, and study timelines.

Qualifications:

• Minimum of 2-3 years of clinical research coordinator experience at the site level.
• Experience conducting IDE clinical trials required.
• Strong understanding of FDA regulations, ICH-GCP guidelines, and clinical trial management at the site level.
• Exceptional communication, organizational, and interpersonal skills.
• Ability and willingness to travel up to 75% at times via plane, train, car, etc.

Why Join ORCA?

• Become part of a dynamic, fast-growing research startup with substantial opportunities for advancement.
• Engage directly with clinical sites and patients, contributing meaningfully to critical research.
• Enjoy competitive compensation, comprehensive benefits, and flexible remote working arrangements.

If you're dedicated to clinical research excellence and seek an impactful role with significant growth potential, we invite you to apply today!

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