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Clinical Research Associate
2 months ago
We are seeking a highly skilled Clinical Research Associate to join our team at Pharmaceutical Research Associates, Inc. as a Clinical Research Associate - West Coast. This is a fantastic opportunity to work with a leading pharmaceutical company and contribute to the development of new treatments.
Key Responsibilities- Conduct on-site and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes.
- Verify the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations.
- Ensure the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
- Manage investigative site staff to facilitate trial deliverables, such as subject enrollment and data deliverables.
- Verify proper management and accountability of Investigational Product (IP).
- Write and submit reports of investigational site findings and updates applicable tracking systems.
- Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate.
- Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study.
- Assist with resolution of investigational site/data queries.
- Perform key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
- Participate in audit preparation and follow-up activities as needed.
- Independently perform a variety of on-site and off-site monitoring visit types.
- Gather and review information for assigned sites and identify inconsistencies.
- Assess risk and escalate as appropriate.
- Assist with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
- May serve as preceptor, providing training to less experienced clinical team members.
- 2 years of experience supporting clinical trials, including 2 years of on-site monitoring experience.
- In-depth knowledge of the drug development process.
- In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.
- Sound knowledge of applicable policies and procedures, SOPs, work instructions, and other guidance documents.
- Good spoken and written communication skills; good presentation skills.
- Strong interpersonal, collaboration, and time management skills.
- High proficiency with Microsoft Office and company collaboration applications.
- Excellent skill in the utilization of applicable clinical systems.
- Excellent critical thinking skills.
- Excellent organizational skills.
- Ability to focus on detail for extended periods of time; high attention to accuracy.
- Ability to travel extensively.
- Ability to establish and maintain effective working relationships with investigative site staff.
- Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse.
We offer a competitive salary and a range of benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global Employee Assistance Programme.
We are committed to providing an inclusive and accessible environment for all candidates and employees. We are an equal opportunities employer and welcome applications from diverse candidates.
