Senior Clinical Data Standards Jobs in Rochester, NY

This is what you will do:

The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The Sr. CRA works in close collaboration with (Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level.

The Sr. CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study.

The Sr. CRA is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

A Sr. CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg. Lead CRA, etc).

You will be responsible for:

• Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
• Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalate them as appropriate.
• Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
• Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plans.
• Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)
• Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs.
• Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF
• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
• Contributing to the nomination and selection of potential investigators and assisting with feasibility activities
• Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders, as needed.
• Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to PMCO, Director COM, HCO and/or Quality Group as required.
• Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with PMCO, Director COM, and Quality Group.

You will need to have:

• Minimum of 4 years of CRA monitoring experience
• Bachelors degree in related discipline, preferably in life science, or equivalent qualification
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Excellent knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
• Good understanding of the drug development process.
• Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to detail.
• Excellent written and verbal communication skills.
• Excellent collaboration and interpersonal skills.
• Good negotiation skills.
• Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
• Valid driving license

We would prefer for you to have:

• Ability to work in an environment of remote collaborators and in a matrix reporting structure
• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Proactivity and assertive when communicating with internal stakeholders and sites
• Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Experience in all study phases and in rare medical conditions preferred.

Date Posted

Closing Date

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