Clinical Research Associate
Alexion Pharmaceuticals, Inc., Wilmington, DE, United States
This Is What You Will Do
The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at their assigned sites and is an active participant in the local study team(s). The CRA works in close collaboration with local team members (Project Management Clinical Operations, Study Start-Up manager, Clinical Study Assistant and other CRAs in Clinical Operations Management) to ensure that study commitments are achieved in a timely and efficient manner on a site level. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure delivery and compliance.
You Will Be Responsible For
Performing identification, selection, initiation, monitoring, site data review and closeout activities/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 escalating 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 implement 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 providing timely feedback 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 Global Study team, local study team, Country Operations Line Management and/or Quality Group, representatives as required.
Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members (e.g., PMCO, Country Operations Line Management, and Quality Group).
You Will Need To Have
Minimum of 1 year of CRA monitoring experience.
Bachelor’s degree in a 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 (*) – to be deleted if not required in a country.
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at their assigned sites and is an active participant in the local study team(s). The CRA works in close collaboration with local team members (Project Management Clinical Operations, Study Start-Up manager, Clinical Study Assistant and other CRAs in Clinical Operations Management) to ensure that study commitments are achieved in a timely and efficient manner on a site level. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure delivery and compliance.
You Will Be Responsible For
Performing identification, selection, initiation, monitoring, site data review and closeout activities/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 escalating 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 implement 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 providing timely feedback 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 Global Study team, local study team, Country Operations Line Management and/or Quality Group, representatives as required.
Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members (e.g., PMCO, Country Operations Line Management, and Quality Group).
You Will Need To Have
Minimum of 1 year of CRA monitoring experience.
Bachelor’s degree in a 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 (*) – to be deleted if not required in a country.
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr