CRA/Clinical Site Monitor (field-based) - CO, NE, KS

Astellas Pharma • Denver, CO

230d • $122,500 - $175,000 • Hybrid

About The Position

A Clinical Site Monitor serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Clinical Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Clinical Site Monitor will partner with Clinical Trial Lead (CTL), Clinical Trial Manager (CTM), Clinical Trial Specialist (CTS), and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.

Requirements

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience.
• 5 years onsite monitoring experience.
• A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong critical thinking and problem-solving skills.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel up to 40% with overnight stay away from home.
• Proficient in speaking and writing English.

Nice To Haves

• Experience working cross-functionally and in matrix teams.
• Experience in executing Lead CSM role.
• Experience mentoring more junior site monitors or site managers.
• Experience working in early development studies.

Responsibilities

• Acts as primary local company contact for assigned sites for specific trials.
• Develops meaningful site relationships through consistent collaborative communication and engagement.
• May participate in site feasibility and/or pre-trial site assessment visits.
• Attends/participates in investigator meetings as needed.
• May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study.
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring, site management, and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
• Ensures ongoing adequacy of site (facilities, staff) for trial conduct.
• Ensures source and other site documentation is adequate and in compliance with ALCOA-CCEA.
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
• Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
• Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
• Fully documents trial related activities, in particular monitoring.
• Aligns with relevant training requirements.
• Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits.
• Prepares trial sites for close out, conduct final close out visit.
• Establishes and maintains good working relationships with internal and external stakeholders.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Management of Companies and Enterprises
• Education Level: Bachelor's degree