Sr. Clinical Research Associate (CRA) will play a vital role in the successful management of Catalyst Clinical Trials from study startup through study completion. The responsibilities include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP guidelines, and all applicable regulatory requirements.

This is a remote, home-based role.

Primary Duties (Included but not limited to)

• Participate in site/vendor selection process.
• Plan and perform various study start-up activities.
• Perform site evaluation, initiation, monitoring, and close-out visits remotely and on-site, per study requirements.
• Be responsible for planning, overseeing, and conducting correspondence with the assigned sites.
• Oversee clinical research sites to ensure adherence to SOPs, ICG/GCP and regulatory requirements.
• Track day to day site activities and have current data available for clinical operations management team upon request.
• Assist in the development of content and/or provide technical expertise for development of essential clinical documents.
• Foster strong relationships with sites and vendors.
• Be able to work with and oversee CROs for fully outsourced studies.
• Support audit/inspection preparation to ensure Catalyst as well as sites’ inspection readiness

Education and Experience Requirements

• Bachelor’s degree with at least 5 years of relevant clinical trials experience.
• Extensive knowledge of applicable clinical research regulatory requirements, including ICH/GCP guidelines
• Experience in CTMS, EDC and eTMF systems.
• Experience in reviewing, analyzing, and understanding clinical trial data.
• Ability to prioritize within a busy environment and produce work to meet tight deadlines.
• RN and /or MS preferred.
• Ability to travel up to 50% of time as needed to meet the assigned study requirements.

Qualifications and Skill Requirements

• Ability to work independently, with little supervision.
• Excellent interpersonal, communication, writing, and presentation skills.
• Superior organizational skills with strong attention to details
• Proficiency in MS Office, Adobe Acrobat, and other industry-standard software.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
• Motivated, detail oriented and good problem-solving ability.

EEO Statement

Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.  

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.