Clinical Trials Operations Specialist

Monte Rosa Therapeutics, Inc; Boston (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Monte Rosa Therapeutics, Inc. is seeking a detail-oriented Clinical Operations Associate to support planning, start-up, maintenance, and closeout of clinical trials.

Reporting to Head of Clinical Operations, you will help ensure trial execution runs smoothly across sites and vendors. The role requires at least 2 years of clinical research experience, knowledge of ICH/GCP and FDA regulations, and strong organization.

Qualifications

• BA/BS degree required with a minimum of 2 years relevant clinical research experience.
• 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; ability to work independently.
• Experience with eTMFs strongly preferred.

Responsibilities

• Contribute to development of study-related documents (Clinical protocols, ICFs, IBs, monitoring plans, study manuals, etc.).
• Partner with Investigators and clinical site staff to ensure optimal Sponsor-Site relationships.
• Review study-specific essential regulatory document packets prior to site activations.
• Participate in the ongoing review and cleaning of clinical trial data.
• Assist with the management of tracking, logistics and quality operations for biological samples to help ensure that sample inventories are accurate and up to date.
• Attend and provide support in meeting scheduling and distribution of meeting agendas/minutes.
• Review monitoring reports and protocol deviations to help track issues and data trends at sites.
• Assist with IMP tracking to verify adequate supply at sites and depots.
• In conjunction with the CRO, manage submission of documents to and maintenance of the TMF, to ensure continual inspection-readiness.
• Support the study finance and contract processes for 3rd party vendors (invoice tracking, approval and accruals).
• Effectively communicate trial details to ensure that all team members are kept informed.
• Participate in SOP development and process improvement projects (as necessary).

Skills

Organization & time management

Cross-functional collaboration

Attention to detail

Effective communication

Education

BA/BS degree

Tools

eTMF systems

Job description

Monte Rosa Therapeutics, Inc. is seeking a detail-oriented Clinical Operations Associate to support planning, start-up, maintenance, and closeout of clinical trials.

Reporting to Head of Clinical Operations, you will help ensure trial execution runs smoothly across sites and vendors. The role requires at least 2 years of clinical research experience, knowledge of ICH/GCP and FDA regulations, and strong organization.