Job summary
Job post source
This job is directly from Catalyst Clinical Research
Job overview
The Senior Clinical Research Associate at Catalyst Clinical Research monitors clinical trial programs and manages regional trial sites to support biopharmaceutical and biotechnology development, ensuring compliance with regulations and company standards.
Responsibilities and impact
The role involves traveling up to 80% to monitor clinical trials, conducting site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations, communicating with site staff and internal teams, assisting with investigator meetings and FDA submissions, managing time and budget effectively, and collaborating with the clinical project team and extended study team.
Experience and skills
Candidates must have a bachelor's degree in a science or health-related field or 7 years equivalent experience, at least 5 years of clinical research experience with direct site monitoring, 3 years of recent oncology trial experience, strong knowledge of clinical trial monitoring and regulations, organizational skills, communication skills, flexibility for travel, and proficiency with standard computer applications.
Company information
Catalyst Clinical Research offers customizable solutions to biopharmaceutical and biotechnology industries through oncology and multi-therapeutic CRO services, leveraging innovative technology and a global presence to advance clinical studies.
Job location and travel
The position requires up to 80% travel within an assigned territory and may include maintaining a home office if working remotely.
Unique job features
The job features extensive travel, collaboration with diverse clinical teams, and involvement in FDA audit preparations and investigator meetings.
Company overview
Catalyst Clinical Research is a global clinical development organization that provides customizable clinical research solutions to the biopharmaceutical industry. They specialize in offering full-service clinical trial management, functional service provision, and strategic resourcing. The company generates revenue by partnering with pharmaceutical and biotechnology companies to manage and execute clinical trials efficiently. Founded in 2013, Catalyst has grown through strategic acquisitions and a focus on therapeutic expertise, particularly in oncology and rare diseases, making it a significant player in the clinical research sector.
How to land this job
Tailor your resume to emphasize your extensive experience in clinical trial monitoring, especially your expertise in oncology trials and compliance with ICH/GCP and PhRMA guidelines, as these are crucial for Catalyst Clinical Research's Senior Clinical Research Associate role.
Highlight your ability to manage multiple clinical trial sites, coordinate with cross-functional teams, and your strong communication skills to demonstrate your capacity to effectively report study status and resolve site issues.
Apply through multiple platforms including Catalyst Clinical Research’s corporate website and LinkedIn to maximize your application’s visibility and ensure you reach the right hiring managers.
Connect with current Senior Clinical Research Associates or team members within the oncology division at Catalyst Clinical Research on LinkedIn; use ice breakers like commenting on their recent projects or asking about how Catalyst supports remote monitoring and travel demands in this role.
Optimize your resume for ATS by incorporating keywords such as 'clinical trial monitoring,' 'oncology clinical trials,' 'ICH/GCP compliance,' 'site management,' and 'FDA audit preparation' to ensure your resume passes initial screenings.
Leverage Jennie Johnson’s Power Apply feature to automate tailored applications, identify multiple job portals for applying, and find relevant LinkedIn contacts to network with, saving you valuable time and increasing your chances of landing the role.
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