Senior Clinical Research Associate Catabasis
We are seeking a Senior Clinical Research Associate 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 in cardiovascular / metabolic therapeutic areas. This position reports to the Director, Clinical Operations.
Oversee the management of the overall activities of relevant CROs, vendors and monitors either in-house or regionally based;
Oversee the evaluation of potential clinical investigators and sites
Oversee the development and coordinates review of key deliverables, such as the study synopsis, protocol, informed consent forms, study guidelines, operations manuals; CSRs
Maintains study timelines
Manage escalation of study related issues and establishes appropriate course of action
Proven track record of anticipating potential study issues and preparing contingency plans with minimal oversight
Responsible for the conduct of training and kick-off meetings with sites and vendors
Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites and vendors
3-5 yrs. experience of biotech / pharmaceutical clinical operations experience
Experience in managing the execution of complex phase 1-3 clinical trials in cardiovascular / metabolic related clinical therapeutic areas is highly desirable
Strong experience in CRO and vendor management to support clinical trials
Strong knowledge of FDA regulations and GCP / ICH guidelines regarding clinical trial management
Ability to ?roll up your sleeves? and individually contribute results to clinical operations and company-wide goals
Demonstrated skills in writing/reviewing clinical study protocols, CRF, and study documentation development, CSR?s, regulatory documents (including IND, CTA documents and annual/periodic updates).
Bachelor?s degree in health sciences or related field, required; Master?s preferred.
Superior verbal and written communication and interpersonal skills, including a positive and professional attitude to tasks and projects
Demonstrated ability to meet short-term deadlines and multi-task in a very fast-paced work environment with little direct supervision
Demonstrated computer skills using MS Office Suite (Word, Excel, PowerPoint, Outlook and Project) software
Ability to travel domestically and internationally
||Cambridge, MA |