Clinical Trials Associate
Monte Rosa Therapeutics, Inc
Summary
We are seeking an energetic and highly motivated individual to join our Clinical Operations team. This position reports to the Head of Clinical Operations and is an opportunity to significantly contribute to the growth and development of a top-tier Biotech company. The COA position is focused on providing support associated with the planning, start-up, maintenance, and closeout of clinical trials. The ideal candidate will be proactive and detail oriented with a desire to be involved in all aspects of clinical trial execution.
Job description
Overview
We are seeking an energetic and highly motivated individual to join our Clinical Operations team. This position reports to the Head of Clinical Operations and is an opportunity to significantly contribute to the growth and development of a top-tier Biotech company. The COA position is focused on providing support associated with the planning, start-up, maintenance, and closeout of clinical trials. The ideal candidate will be proactive and detail oriented with a desire to be involved in all aspects of clinical trial execution.
Responsibilities
- Contribute to the 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)
Qualifications
- BA/BS degree required with a minimum of 2 years relevant clinical research experience working at an Investigator Site, Sponsor or Clinical Research Organization.
- 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
Requirements
- BA/BS degree required
- Minimum of 2 years relevant clinical research experience working at an Investigator Site, Sponsor or Clinical Research Organization
- 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
- Capacity to work independently and prioritize multiple projects
- Experience working with eTMFs strongly preferred
Company overview
Monte Rosa Therapeutics is a clinical-stage biotechnology company pioneering the development of highly selective molecular glue degrader (MGD) medicines for patients with serious diseases. Founded in 2018 and headquartered in Boston, Massachusetts with operations in Basel, Switzerland, the company focuses on oncology, autoimmune and inflammatory diseases. Monte Rosa's proprietary QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to rationally design MGDs with unprecedented selectivity. The company has developed the industry's leading pipeline of first-in-class and only-in-class MGDs, with three programs currently in clinical trials. Monte Rosa's innovative approach targets previously undruggable proteins by inducing specific protein degradation, offering potential treatments for diseases that other modalities cannot address. The company maintains strategic collaborations with leading pharmaceutical companies in immunology, oncology, and neurology, and is publicly traded on NASDAQ under the ticker symbol GLUE.