Senior Clinical Research Associate

Catalyst Clinical Research; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

A forward-thinking company is seeking a Senior Clinical Research Associate to lead clinical trial programs and manage regional sites. This role involves extensive travel, monitoring clinical trials, and ensuring compliance with regulations. The ideal candidate will have a strong background in clinical research, particularly in oncology, and possess excellent communication and organizational skills. Join a dynamic team dedicated to advancing clinical studies and making a significant impact in the biopharmaceutical industry.

Qualifications

• 5+ years of clinical research experience with site monitoring.
• Strong knowledge of clinical trial regulations and methodology.

Responsibilities

• Monitor clinical trials, conduct site evaluations, and manage FDA audit preparations.
• Communicate effectively with site staff and manage study status.

Skills

Clinical Trial Monitoring

Regulatory Knowledge

Communication Skills

Organizational Skills

Interpersonal Skills

Education

Bachelor’s Degree in Science or Health-related Field

7 Years of Industry Experience

Tools

Standard Computer Applications

Job description

Join to apply for the Senior Clinical Research Associate role at Catalyst Clinical Research.

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

As a Senior Clinical Research Associate, you will monitor clinical trial programs and manage regional clinical trial sites to support biological and pharmaceutical developmental programs in a manner consistent with relevant regulations including ICH/GCP and PhRMA guidelines, along with Catalyst Clinical Research’s SOPs and practices. You will collaborate with an assigned clinical research team to provide input on site selection, study initiation, conflict resolution, and audit responses. Effective communication of findings with in-house personnel is essential.

Responsibilities include but are not limited to:

• Travel up to 80% within an assigned territory, monitor clinical trials according to plans, conduct site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations. Develop territory to broaden research site selection.
• Communicate effectively with site staff and Catalyst personnel to report study status, disseminate information, and resolve issues; respond to audit findings.
• Partner with the clinical project team.
• Assist with Investigator Meetings, data collection, and FDA submissions.
• Maintain a home office if working remotely.
• Manage activities to meet budget and timeline goals.
• Participate in meetings to stay current on regulations and guidelines.
• Collaborate with Study Manager and Project Manager.
• Support Field Monitors from the Clinical Trial Associate team.
• Work closely with sponsors, vendors, data managers, statisticians, medical monitors, and other staff.

Qualifications:

• Bachelor’s degree in a science or health-related field or 7 years of industry experience.
• At least 5 years’ experience in clinical research with site monitoring, including 3 years in oncology trials.
• Strong knowledge of clinical trial monitoring, regulations, and research methodology.
• Excellent organizational, communication, and interpersonal skills.
• Willingness to travel routinely.
• Proficiency in standard computer applications.

Applicants must be authorized to work in the U.S. without sponsorship.