Sr. Clinical Research Associate

About the role

As a Senior Clinical Research Associate at Bamboohr, you will play a role in advancing our clinical research initiatives. You will be responsible for overseeing clinical trials, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to drive project success. This position offers an to contribute to innovative therapies in a dynamic environment located in South San Francisco, California.

Key facts

What you'll do

• Lead the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols and regulatory requirements.
• Collaborate with clinical project managers to develop study timelines, budgets, and resource allocation strategies.
• Conduct site selection, initiation, monitoring, and close-out visits to ensure compliance with Good Clinical Practice (GCP) and other regulatory guidelines.
• Maintain comprehensive and accurate study documentation, including site visit reports, regulatory submissions, and trial master files.
• Act as a primary point of contact for clinical sites, fostering strong relationships and providing ongoing support throughout the trial process.
• Identify and resolve issues at clinical sites, ensuring timely communication and escalation of concerns to project leadership.
• Collaborate with data management teams to ensure accurate and timely data collection and entry, facilitating data integrity and quality.
• Participate in the development and review of clinical trial protocols, informed consent forms, and other study-related documents.
• Assist in the training and mentoring of junior clinical research staff, promoting best practices and professional development.
• Contribute to the preparation of clinical study reports and presentations for internal and external stakeholders.
• Stay updated on industry trends, regulatory changes, and advancements in clinical research methodologies.
• Support audits and inspections by regulatory authorities, ensuring that all documentation and processes are in compliance with applicable regulations.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• A minimum of 5 years of experience in clinical research, with a focus on monitoring and site management.
• Thorough understanding of GCP, ICH guidelines, and regulatory requirements for clinical trials.
• Proven track record of managing multiple clinical studies simultaneously, demonstrating strong organizational skills.
• Excellent communication and interpersonal skills, with the ability to build rapport with diverse stakeholders.
• Strong analytical and problem-solving abilities, with attention to detail in all aspects of work.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Ability to work independently and as part of a collaborative team in a fast-paced environment.
• Willingness to travel to clinical sites as needed, up to 30% of the time.

Nice to have

• Experience in oncology or rare disease clinical trials is a plus.
• Familiarity with regulatory submissions and interactions with health authorities.
• Certification as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) is advantageous.
• Knowledge of statistical analysis and data interpretation related to clinical trials.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software.
• Experience with electronic medical records (EMR) systems and clinical trial management software.
• Strong understanding of data management processes and tools used in clinical research.
• Familiarity with statistical software such as SAS or R is a plus.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites.
• Bamboohr is committed to fostering a diverse and inclusive workplace, encouraging applicants from all backgrounds to apply.
• The successful candidate will be expected to demonstrate a commitment to ethical conduct and compliance with industry standards.
• Additional training and development opportunities will be provided to support your career growth within the organization.

If you are about clinical research and eager to make a meaningful impact in the field of healthcare, we invite you to apply for the Senior Clinical Research Associate position at Bamboohr. Join us in our mission to develop innovative therapies that improve patient outcomes and enhance quality of life.

About the company

Medicine is our platform. Accessibility is our cure.