Senior Clinical Trial Associate

Scorpion Therapeutics; Cambridge (MA); On-site; USD 110,000 - 115,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits

Job summary

Scorpion Therapeutics in Cambridge, MA is seeking a Senior Clinical Trial Associate to provide administrative and operational support across in-house and outsourced trials. You will help with start-up, maintenance, and closeout activities, while coordinating with CROs, vendors, and investigator sites.

The role requires a Bachelors degree and several years in clinical trials, with preference for FDA/EMA regulatory knowledge and ICH/GCP familiarity.

Qualifications

• Bachelors degree required.
• Minimum 3 years related industry experience required; Senior CTA requires 2 years as Clinical Trial Associate.
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines preferred.
• Working knowledge of clinical protocols.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook.
• Experience leading small group meetings and/or managing vendor relationships.

Responsibilities

• Provide administrative and operational support across all study activities for in-house and outsourced trials.
• Support study start-up, maintenance, and closeout activities.
• Manage study-related vendors; serve as point of contact for CROs, contract labs, and other vendors.
• Act as key point of contact for investigator sites to coordinate study-related activities.
• Oversee sample collection, shipment, and analyses.
• Reconcile and track study processes; identify risks and proactively resolve issues with CROs.
• Assist with vendor management plans and compile study/quality metrics for CTL and review meetings.
• Maintain documentation and correspondence with vendors and sites.
• Ensure receipt, completeness, accuracy, and appropriate filing (TMF, SharePoint, and other systems) of clinical/administrative documents.
• Support central IRB submissions and review site-specific informed consent forms.
• Coordinate electronic distribution and/or shipment of study materials.
• Track vendor and site contracts, budgets, invoices, and payments.
• Contribute to TMF plan; perform periodic QC reviews and TMF reconciliation.
• Perform study/department administrative tasks (agendas, minutes, meeting planning/presentations)

Skills

Communication

Organization

Detail-oriented

Teamwork

Verbal communication

Education

Bachelors degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Senior Clinical Trial Associate

Responsibilities

• Provide administrative and operational support across all study activities for in-house and outsourced trials
• Support study start-up, maintenance, and closeout activities
• Manage study-related vendors; serve as point of contact for CROs, contract labs, and other vendors
• Act as key point of contact for investigator sites to coordinate study-related activities
• Oversee sample collection, shipment, and analyses
• Reconcile and track study processes; identify risks and proactively resolve issues with CROs
• Assist with vendor management plans and compile study/quality metrics for CTL and review meetings
• Maintain documentation and correspondence with vendors and sites
• Ensure receipt, completeness, accuracy, and appropriate filing (TMF, SharePoint, and other systems) of clinical/administrative documents
• Support central IRB submissions and review site-specific informed consent forms
• Coordinate electronic distribution and/or shipment of study materials
• Track vendor and site contracts, budgets, invoices, and payments
• Contribute to TMF plan; perform periodic QC reviews and TMF reconciliation
• Perform study/department administrative tasks (agendas, minutes, meeting planning/presentations)

Qualifications

• Bachelor’s degree required
• Minimum 3 years related industry experience required; Senior CTA requires 2 years as Clinical Trial Associate
• Familiarity with FDA/EMA regulatory requirements and ICH/GCP guidelines preferred
• Working knowledge of clinical protocols
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook
• Experience leading small group meetings and/or managing vendor relationships

Skills/Attributes

• Highly motivated; works well in a fast-paced environment
• Excellent teamwork, organization, detail orientation, and written/verbal communication
• Ability to accommodate flexible schedule per trial priorities

Benefits/Compensation

• Base pay range: $110,000–$115,000 annually; total compensation includes equity, bonus, and benefits