Draig Therapeutics · 4 weeks ago
Clinical Research Associate (CRA) I
Greater Boston
Full-time
Hybrid
New Grad, Entry LevelDraig Therapeutics is an exciting, rapidly growing clinical-stage biotech focused on transforming the treatment landscape for depression and neurological disorders. The Clinical Research Associate I plays a crucial role in providing operational and administrative support for clinical studies, ensuring they run smoothly and comply with regulatory requirements.
BiopharmaBiotechnologyClinical TrialsTherapeutics
Responsibilities
Review and/or QC of study plans and manuals produced by the CRO, as required
Attendance at regular Draig and CRO team meetings, as required
Review and/or QC of Regulatory/Ethics submission packs for the participating countries to ensure accuracy and consistency of submission documentation
Oversight of the green light process for study start at the study sites, if required
Management/oversight of risk assessment activities for the trial
Oversight of laboratory-related activities, to include review of laboratory documentation (manuals, plans) and tracking of sample shipment/management as required
Oversight of other clinical trial vendors, as agreed with the Clinical Lead
Assist the Clinical Lead in oversight of monitoring activities, including review of the Trial Monitoring plan and monitoring visit reports
Oversight of the management of the CRO’s electronic Trial Master file, including content review and completeness checks, regular formal QC checks, and following up on missing documentation
Tracking and reporting on clinical trial activities
Qualification
Required
A bachelor's degree in a life science or health-related field (e.g., biology, biochemistry, pharmacy, nursing, health sciences, medical technology, public health, psychology, or clinical research)
Ability to conduct on‑site and remote monitoring visits, perform source data verification, review essential documents, assess site performance, and support patient safety and data integrity
Up‑to‑date GCP/ICH training and site‑level or sponsor‑level compliance training
Strategic thinker with excellent execution and communication abilities
Strong understanding of trial phases, protocol requirements, ICH‑GCP, and local regulatory/ethics frameworks
High accuracy in reviewing source data, CRFs/EDC entries, and documentation; ability to spot protocol deviations and trends
Embodies and promotes collaboration and works effectively with others across the organization to achieve goals
Drives execution of strategic and operating plans while maintaining operational effectiveness
Establishes and maintains strong relationships internally and externally
Company
Draig Therapeutics
Draig Therapeutics is a clinical-stage biopharmaceutical startup.
Founded in 2024
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$140MKey Investors
Access Biotechnology
2025-06-18Series A· $140M
2024-09-01Seed
Leadership Team
Ivana Magovčević-Liebisch
President and CEO
Inderjit Kaul
Chief Medical Officer
Recent News
businessweekly.co.uk
2025-12-02
Minerva Neurosciences, Inc
2025-11-19
2025-11-09
Company data provided by crunchbase