Senior Clinical Research Associate

Senior Clinical Research Associate

Job Summary

The Sr. CRA is responsible for the execution of key clinical trial activities as delegated by the Clinical Trial lead. Key responsibilities focus on the logistical support for a trial which includes monitoring and management of clinical sites, vendor management and data review, query generation activities on single center or global studies.

Skills & Attributes

Clinical trial experience that includes international Phase 1-3 trials, involving CROs or IST trial led by Investigators, from study set-up through to completion.

Experience with Gastrointestinal, hematology and/or orphan drug trials preferred. High level of appreciation and understanding of the feasibility, regulatory and start-up processes, together along with on-site monitoring and site management. Good overall understanding of the major areas within clinical development. Excellent communication and interpersonal skills, along with attention to detail and critical thinking skills. Strong written and spoken English. Ability to collaborate, problem solve and work in a small dynamic organization with minimal supervision, to achieve personal and collective goals.

Experience Required

4+ years as a CRA within Biotech/Pharma, Academia or CRO

Education Required

Bachelor's Degree, preferably in biological science.

Travel Required

Yes, up to 25%

Core Responsibilities

Overall Study Execution

* Part of the clinical study team and takes a lead on execution by performing key activities as delegated by the Clinical Study lead, including but not limited to:

* Develop and/or review key study operational documents (e.g., study reference manual, laboratory and pharmacy manuals, data management plan, query generation, monitoring plan; review site audit reports) •

* May assist with development and coordination of any trial-specific sub-studies •

* Assist with selection, set-up and management of select vendors and clinical sites •

* Ensure activities under CRA's responsibility are in compliance with GCP/ICH and all local regulatory guidelines

* Identify areas and methods to improve study processes and systems Site Management / Monitoring

* Lead or participate in site monitoring activities, with oversight by CTM, including:

* Evaluation and selection of new investigators

* Draft and/or review study monitoring documents such as monitoring plan, trip report template, monitoring tools, etc.

* Prepare sites for study initiation, including contract/budget finalization, collection/review of regulatory document and review/development of any training materials; conduct site initiation visits, in coordination with CRO

* May conduct interim site monitoring visits according to study monitoring plan and SOPs (including source document verification, eligibility review, AE/SAE review, study drug accountability, regulatory binder review); may conduct co-monitoring visits for studies outsourced to CROs. Activities may include but not limited to:

* Ensure proper documentation of informed consent

* Ensure proper reporting of adverse events and appropriate follow-up

* Perform source document verification of completed CRFs for completeness and accuracy of data

* Review of investigator regulatory document binder/files

* Work closely with assigned study sites to identify and resolve site-specific issues

* Ensure routine communication with study sites and that sites are adequately informed of necessary study information

* Review monitoring quality metrics and CRO monitoring reports; identify risks and communicate issues to CPM for resolution

* Provide written reports and follow-up letters summarizing site visits, site communication and study-related discussions

* Assist with planning and coordination of study Investigator's Meetings and other external study meetings (DMC/DSMB, steering committee, etc.) Vendor Management

* Support study vendor management by performing key activities as delegated by study CTM, including but not limited to:

* Participate in evaluation of new vendors (CROs, labs, central readers, EDC, etc.) by drafting and/or reviewing RFPs, analyzing responses and drafting work orders for select vendors
• Manage the day to day interactions with…