Clinical Research Associate II

$66,000 - $80,000/Yr

CPC Clinical Research - Aurora, CO

Full-time - Mid Level

Remote - Aurora, CO

About the position

The Clinical Research Associate II position at CPC Clinical Research involves overseeing clinical trials to ensure compliance with protocols, federal regulations, and Good Clinical Practice (GCP) guidelines. The role requires travel to various sites, conducting monitoring visits, and maintaining regulatory documents. The ideal candidate will have a strong background in clinical research, excellent interpersonal skills, and the ability to adapt to changing environments.

Responsibilities

• Travel to sites conducting clinical trials to ensure compliance with protocols, federal regulations, and ICH-GCP guidelines.
• Conduct monitoring visits including Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits.
• Oversee drug accountability, storage, and disposition at investigative sites.
• Collect and maintain investigator regulatory documents.
• Conduct Site Endpoint Evaluation Visits as required by contract.
• Ensure proper maintenance of required records for monitoring activities and regulatory documents per CPC requirements.
• Help produce study materials, including Case Report Forms, Study Procedure Manuals, and source documents.
• Assist with the selection of qualified sites and investigators for research protocols.
• Develop and present materials for investigator meetings and sponsor/CRO training.
• Provide training to other CRAs and staff at selected research sites.

Requirements

• Nursing or bachelor's degree preferred but not required.
• Minimum of three years of experience in clinical trials research.
• At least one year of experience as a CRA.
• Demonstrated mastery of CRA I responsibilities.
• Thorough knowledge of Good Clinical Practice guidelines and applicable FDA and ICH regulations.
• Understanding of the drug development process.
• Intermediate proficiency in MS Office.
• Experience with EDC and CTMS strongly preferred.
• Good interpersonal communication skills, organizational skills, and attention to detail.
• Ability to complete tasks accurately and timely with minimal supervision.
• Ability to manage conflicts and resolve problems effectively.
• Willingness to travel up to 60%.

Nice-to-haves

• Experience with EDC and CTMS.

Benefits

• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Paid holidays
• Paid sick time
• Vision insurance