Clinical Research Associate II Catabasis
THIS JOB HAS EXPIRED We are seeking a Clinical Research Associate II to join the Clinical Operations team at Catabasis. The role will be a key contributor to the company?s clinical development and primarily responsible for the hands-on management and monitoring of clinical studies. This person will work closely with the CRO in study start-up, patient recruitment, and study monitoring and study management. This position reports to the Director, Clinical Operations.
Establishes and maintains regular contact with CRO, vendors and study sites to ensure GCP/ICH/protocol compliance, and assessment of accrual rates.
Ensures site compliance with study protocols. Works with site personnel and study team to prevent, address and resolve issues.
Assists in study start-up activities including site selection and review of regulatory documents and ensures site is qualified for the study.
Independently perform tasks in CTMS, EDC and CRO / vendor specific systems
Perform periodic co-monitoring with CRO/contract monitors to ensure quality site conduct and data entry
Track study progress ensuring timely data collection, monitoring, and query resolution
Oversee site compliance with study protocol
Assist in the creation and review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials
Review monitoring visit reports to identify potential site non-compliance and monitoring deficiencies and ensure sponsor oversight
Manages administration of invoice reconciliation, scoping, and change orders, for clinical trial operations
BS/BA degree or equivalent (background in life sciences preferred)
At least 3-5 yrs. of industry experience (biotech/pharma/ CRO)
Strong understanding of ICH, GCP, and relevant regulatory requirements
Organized and able to produce high quality work independently
Good communication skills and proficiency with Microsoft Outlook and Office
Must have high degree of accuracy and attention to detail
Ability to travel up to 20% of time
||Cambridge, MA |
THIS JOB HAS EXPIRED