Dynamic Clinical Trials Associate for Study Execution

Monte Rosa Therapeutics; Boston (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Monte Rosa Therapeutics seeks an energetic Clinical Operations professional to support trial planning, start-up, maintenance and closeout. You will help develop essential study documents, coordinate with investigators, and ensure TMF readiness with CRO collaboration.

The role emphasizes regulatory alignment, data review, sample logistics, and cross-functional teamwork, requiring a BA/BS with 2+ years in clinical research and practical ICH/GCP knowledge.

Qualifications

• BA/BS degree required with a minimum of 2 years relevant clinical research experience at an Investigator Site, Sponsor or CRO.
• Working knowledge of ICH/GCP guidelines and FDA regulations.
• Ability to collaborate effectively with cross-functional team members and external partners.
• Strong organizational and time management skills, including the capacity to work independently and prioritize multiple projects.
• Experience working with eTMFs strongly preferred.

Responsibilities

• Contribute to the development of study-related documents (protocols, ICFs, IBs, monitoring plans, study manuals).
• Partner with Investigators and clinical site staff to ensure Sponsor-Site relationships.
• Review regulatory document packets prior to site activations.
• Participate in ongoing review and cleaning of clinical trial data.
• Assist with tracking, logistics and quality operations for biological samples and inventories.
• Attend and support meeting scheduling and distribution of agendas/minutes.
• Review monitoring reports and protocol deviations to track issues and data trends at sites.
• Assist with IMP tracking to verify adequate supply at sites and depots.
• Manage TMF submission and maintenance with CROs to ensure inspection-readiness.
• Support study finance and contract processes for 3rd party vendors.
• Communicate trial details to keep team members informed.
• Participate in SOP development and process improvement projects.

Skills

ICH/GCP knowledge

Cross-functional collaboration

Time management

eTMF experience

Documentation and regulatory

Education

BA/BS degree

Tools

eTMF systems

Job description

Monte Rosa Therapeutics seeks an energetic Clinical Operations professional to support trial planning, start-up, maintenance and closeout. You will help develop essential study documents, coordinate with investigators, and ensure TMF readiness with CRO collaboration.

The role emphasizes regulatory alignment, data review, sample logistics, and cross-functional teamwork, requiring a BA/BS with 2+ years in clinical research and practical ICH/GCP knowledge.