Clinical Research Coordinator Jobs

About Advarra:

Advarra makes clinical research safer, smarter, and faster. Our integrated solutions help safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance for over 3,500 sponsors, CROs, institutions, academic medical centers, and research consortia.

With trusted and unequaled independent oversight committee services, innovative software solutions for sites, sponsors, and CROs, and experienced consultants with deep-seated connections across the industry, Advarra has the expertise and technology needed to advance clinical research and help our clients make the world a healthier place.

About the Opportunity:

Advarra is seeking a full-time Clinical Research Coordinator with gene therapy or CNS experience required. This is a hybrid, consultant (contractor) role and does not include benefits.

The Clinical Research Coordinator II will be responsible for the following:

• Responsible for data and source documentation.
• Perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study protocol.
• Works under general supervision and direction Principal Investigator, or designated staff, to implement and coordinate research, including administrative procedures.
• Serve independently as an administrative liaison for a range of assigned studies including study feasibility/start-up, implementation, screening, enrollment, and close-out.
• Independently coordinate overall effective operation of designated protocols, which includes development, design, and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.
• Provide support for labor-intensive protocols as needed.
• Participate in maintaining data necessary for audits, supervise audits, and oversee coordination of FDA audits.
• Monitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of subjects.
• Ensures compliance with Good Clinical Research Practice standards.
• Maintain up-to-date working knowledge of regulatory compliance guidelines as defined by the federal regulations, IRBs, and state laws.
• Performs duties and responsibilities in a highly organized manner.
• Schedule participant tests and visits as required by protocol keep subjects informed about test results and follow up.
• Demonstrates problem-solving and conflict resolution while working in a dynamic and complex research environment.
• Assist in the screening for adverse events & documenting in accordance with study procedures.
• Assist Principal Investigator in developing research study-related materials (e.g., feasibility assessments, surveys, regulatory documents, source documents, electronic research charting forms, case report forms).
• Understand and adhere to policies and procedures related to conduct of clinical trials.
• Assist in the screening, enrollment (ensuring inclusion/exclusion criteria are met) and follow-up of research subjects, ensuring protocol compliance and close monitoring while on study.

Requirements:

• Bachelor’s degree with three (3) years of relevant clinical, health related, scientific, business or research experience or Associate’s degree with four (4) years of relevant clinical, health related, scientific, business or research experience.
• 3 years of gene therapy or CNS experience required.
• Current training in human subjects protection education, Good Clinical Practice, and HIPAA Privacy
• CCRP/CCRC/SOCRA certifications or equivalent preferred