Clinical Research Coordinator - Direct Hire at USDM Life Sciences

About USDM
 

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. 

As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is looking for a Clinical Research Coordinator for our client. This is a direct hire role. 

Primary Responsibilities

• Coordinate all aspects of clinical research studies conducted at the site, including participant recruitment, screening, enrollment, and follow-up visits.
• Excellent communication skills, professional etiquette and manners, strong interpersonal skills, and an ability to provide excellent customer service to our patients.
• Liaise with study sponsors, principal investigators, and study staff to ensure adherence to study protocols and timelines.
• Flexible and adaptable, Works well in a team but is self-driven.
• Maintain accurate and current study documentation, including informed consent forms, case report forms, and regulatory submissions.
• Ensure compliance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and institutional policies and procedures.
• Assist in the preparation and submission of regulatory documents for study approval and continued compliance.
• Organize study-related meetings, training, and site visits as required.
• Act as the primary point of contact for study participants, addressing inquiries and offering support throughout the study duration.
• Collaborate with interdisciplinary team members to resolve study-related issues and enhance study performance.
• Undertake additional duties as assigned to support the smooth operation of the clinical research site.

Qualifications

• A minimum of 4 years of experience in clinical research, with a preference for experience in a coordinator role.
• Research experience in clinical research setting Phases I-IV.
• Thorough understanding of clinical research principles, regulations, and best practices.
• Exceptional organizational, communication, and interpersonal skills.
• Ability to work both independently and collaboratively in a dynamic environment.
• Proficiency in Microsoft Office Suite and electronic data capture systems.
• Certification in Clinical Research (e.g., CCRC, CCRP) is preferred.

Education & Certifications

• Bachelor’s degree in a relevant field (e.g., nursing, life sciences, public health) is required; a master’s degree is preferred.

Note: This is a direct hire position with our client.