POSITION OVERVIEW:

Disc Medicine is hiring a new Clinical Trial Associate due to the fast growth of the programs in the clinic.  This position is located within Disc Medicine’s Watertown, MA office, although hybrid work is currently in effect and open for this role.  We are looking for someone to be an integral member of the Clinical Operations team and lead the planning, implementation, and management of early phase clinical research studies.

Excellent organization and oral/written communication skills are required, as is the ability to work in a collaborative, cross-functional team environment and with both in office and remote team members. The CTA will independently perform tasks related to supporting operational strategy, planning, and execution of clinical studies in a fully outsourced model. This position offers the chance to join a team of passionate colleagues with the opportunity for career growth.

RESPONSIBILITIES:

• Provide support for critical day-to-day clinical study activities, including inspection readiness and/or oversight of inspection deliverables and/or milestones, in accordance with established protocols under the general supervision of the CTA Manager.
• Collaborate with Clinical Trial Manager, study teams, vendors, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Support Clinical Trial Manager with preparing and coordinating bi-weekly clinical trial team meetings and finalizing meeting materials such as agendas, slides, and meeting minutes; track and follow up on action items
• Development and/or review and approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, trial reports, ASRs/DSURs, laboratory manuals, pharmacy manuals, and trial status updates
• Ensure audit-ready condition of clinical trial documentation including the trial master file, including leading internal TMF quality reviews with cross functional team members on the study defined cadence
• Track patient samples and reconcile sample discrepancies with sites and applicable central labs; coordinate sample movement and data deliverables on time with business needs and accompanying data deliverable timelines
• Assist finance department to with invoices, clinical projections, and per patient cost estimates
• Work closely with the CRO to support study and site start up activities such as SIV slide development, process flows, contract and budget negotiations, site ICF customizations, assist with answering site IRB questions, etc. to ensure start-up occurs within established timelines
• Review and provide input on clinical monitoring visit reports and ensure that all outstanding follow-up items are closed out in a timely manner.
• Collaborate with internal departments (Legal, Finance, Nonclinical, etc.), CROs, and external vendors.
• Establish and maintain trial-related processes/systems with study vendors such as central labs, clinical supplies, IP depot, and CRO as assigned per protocol requirements
• Help develop and drive timelines and collaborate with cross functional teams to align on deliverables to help support data cuts, conference needs, interim analyses, etc.
• Monitor progress of clinical study activities and report on the progress of assigned clinical trials including budget and timelines
• Oversee the updating and maintenance of patient trackers to accurately reflect all enrolled, screened, and screen-failed patients within the study. Ensure timely completion of patient visits and proactively follow up with sites and CROs regarding any outstanding visits. Provide real-time patient updates to the Clinical Trial Team as needed
• Initiate clinicaltrials.gov updates and publications based on business needs and other study updates
• Participate in the preparation and review of SOPs.
• Perform any other business need identified by their direct line Manager.

 REQUIREMENTS:

• BA/BS required
• Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
• Ability to effectively collaborate with both internal and external study team
• Ability to take initiative and ownership of new activities as they arise
• Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands
• Experience working on project teams is required
• Candidate should be a self-driven individual with skills in organization, building working relationships and communication.