Clinical Research Associate at Actalent United States

About the Position

Clinical Research Associate Job at Actalent, United States

The Clinical Research Associate is responsible for all site-related activities from site initiation through monitoring to close-out, primarily within oncology studies, including prostate cancer and gastrointestinal indications. This role plays a key part in the setup, oversight, and quality of phase II and III clinical trials, ensuring the highest industry standards are consistently met. The position offers a wide variety of monitoring tasks and the opportunity to work across multiple therapeutic indications within dynamic project teams.

Responsibilities

• Oversee all on-site monitoring activities independently, from site initiation through site close-out.
• Plan, conduct, and document all types of on-site monitoring visits, including initiation, routine, and close-out visits.
• Actively participate in study start-up activities, including site feasibility assessments and operational preparation.
• Perform case report form (CRF) review, source data verification (SDV), and timely query resolution.
• Maintain regular communication with investigative sites and manage the day-to-day relationship with site staff.
• Serve as the primary point of contact for in-house support services and external vendors involved in the studies.
• Communicate study progress, risks, and proposed corrective actions to internal project teams.
• Support the regulatory team in preparing documentation for regulatory and ethics submissions.
• Contribute to patient recruitment activities at sites, monitor enrollment targets, and propose supportive actions when needed.
• Ensure the quality, completeness, and accuracy of monitoring visit reports and associated study documentation.
• Adhere to standard operating procedures, Good Clinical Practice (GCP), and all applicable regulatory requirements.
• Collaborate with project teams to resolve operational issues, identify process improvements, and support overall study success.
• Travel frequently to oversee study sites.

Requirements

• College or university degree in Life Sciences, or an equivalent combination of education, training, and experience.
• Completed Bachelor of Science (BSc) degree.
• At least 5 years of independent on-site monitoring experience as a Clinical Research Associate.
• Demonstrated experience with all types of monitoring visits in phase II and III clinical trials.
• Previous experience working as a Clinical Research Associate within a clinical research organization (CRO) or pharmaceutical company.
• Oncology experience, ideally including prostate cancer and gastrointestinal studies.
• Ability to maintain a full working allocation (1.0) on assigned studies.
• Proficiency with MS Office applications (such as Word, Excel, PowerPoint, and Outlook).
• Ability to plan and organize work effectively in a dynamic team environment.
• Strong communication, collaboration, and problem-solving skills.
• Ability and willingness to travel frequently for site visits.
• Proven ability to conduct site initiation, routine monitoring, and close-out visits to a high quality standard.
• Experience supporting site-level recruitment activities and tracking enrollment objectives.
• Strong focus on quality in drafting and reviewing monitoring visit reports and study documentation.

Nice to Have

• Experience with contract-related activities in clinical trials.
• Experience with multiple or complex oncology studies.
• In-depth knowledge of Good Clinical Practice (GCP) and applicable clinical trial regulations.
• Experience working with sites across multiple Canadian provinces.

We Offer

• Competitive salary range of $75.00 - $95.00/hr.
• Fully remote position.
• Opportunity to work within multidisciplinary project teams in a dynamic environment.
• Extensive use of MS Office applications and clinical trial management systems.
• Focus on oncology studies, particularly phase II and III trials.

About the Company

Actalent is a leading provider of innovative staffing and workforce solutions, dedicated to helping clients achieve their goals through exceptional talent and expertise. Our commitment to quality, collaboration, and scientific rigor drives our success in the clinical research field.

Job Type & Location

• Job Type: Contract
• Location: Calgary, AB (Remote)

Apply Now

Join our team and contribute to the advancement of clinical research in oncology studies. Apply now to embark on a rewarding career with Actalent.