Job Description

CRA/Clinical Site Monitor (field-based) - Boston

Join to apply for the CRA/Clinical Site Monitor (field-based) - Boston role at Astellas Pharma

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at

Purpose And Scope

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 SOPs, GCP, and applicable regulations from study start-up through site closure. The Clinical Site Manager will manage the site/sponsor relationship related to clinical trial delivery through consistent communication and support. The CSM 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.

Responsibilities May Include Assisting With Or Primary Responsibility For

• Site Selection
• Pre-trial assessment
• Site level Study Participant recruitment/retention plans
• Site Activation/Initiation
• On-site and remote monitoring
• Overall site relationship management in collaboration with other sponsor roles that interact with the site
• Close-out activities

Essential Job Responsibilities

• Acts as primary local company contact for assigned sites for specific trials, including early and late phase trials.
• Develops meaningful site relationships through consistent collaborative communication and engagement.
• Participates in site feasibility and/or pre-trial site assessment visits.
• Attends/participates in investigator meetings as needed.
• May serve as Lead CSM for specific studies, providing oversight and support for other CSMs, and establishing site monitoring strategy.
• Drives activities in site initiation, monitoring, management, and close-out according to SOPs, WIs, and policies, including risk-based monitoring approaches.
• Ensures site staff are trained, training records are complete, and site activation is expedited.
• Ensures compliance with study protocol, ICH-GCP, and local regulations.
• Maintains adequate site facilities and staff for trial conduct.
• Ensures source and documentation are compliant with ALCOA-CCEA standards.
• Participates in recruitment strategy and implementation.
• Manages clinical supplies, drug handling, storage, and destruction.
• Oversees data entry, query resolution, and data quality.
• Reports adverse events within timelines and documents appropriately.
• Maintains trial documentation and manages archiving.
• Develops therapeutic knowledge and acts as local protocol expert.
• Coordinates with CTL on CAPA activities and site audits.
• Prepares sites for close-out and final visits.
• Builds and maintains relationships with investigators, coordinators, and site staff.
• Participates in health authority and IRB/IEC submissions as needed.

Quantitative Dimensions

Responsible for up to 10 sites across 2-4 protocols, managing travel budgets within guidelines.

Organizational Context

Reports to the regional Site Management Lead. May mentor less experienced staff and oversee contract team members, with a matrix relationship to study teams.

Qualifications

Required

• BA/BS degree with ?5 years in pharmaceutical drug development or equivalent experience.
• 5 years onsite monitoring experience.
• At least 2 years in Oncology, Ophthalmology, Gene Therapy, or relevant therapeutic areas.
• Strong knowledge of GCP, regulations, protocols, and monitoring guidelines.
• Critical thinking and problem-solving skills.
• Proficient IT skills and experience with company systems.
• Willing to travel up to 40%, including overnight stays.
• Fluent in English; additional local language skills may be required.
• Excellent communication skills.

Preferred

• Experience in cross-functional and matrix teams.
• Experience as Lead CSM.
• Mentoring experience.
• Experience in early development studies.

Benefits

• Medical, Dental, Vision Insurance
• Generous PTO, holidays, and breaks
• 401(k) match and company contributions
• Paid life insurance
• Bonuses and incentive programs
• Referral bonuses

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