About the position
The Senior Clinical Research Associate (Sr. CRA) plays a crucial role in the delivery of clinical studies at allocated sites, actively participating in local country teams. This position requires close collaboration with other Clinical Research Associates (CRAs) and the Country Operations Management (COM) Team to ensure that study commitments are met efficiently and on time. The Sr. CRA serves as the primary contact for study sites, responsible for monitoring study conduct to ensure compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. The role encompasses the selection, initiation, monitoring, and closure of assigned sites in clinical studies, ensuring that sites fulfill their commitments in individual studies. A Sr. CRA with demonstrated skills and experience may also take on additional responsibilities, such as serving as a Lead CRA. Key responsibilities include performing selection, initiation, interim monitoring, and closeout visits (both remote and onsite) in accordance with the timelines specified in the Clinical Monitoring Plan (CMP). The Sr. CRA is tasked with driving performance at the sites, proactively identifying and resolving study-related issues, and escalating them as necessary. Training and supporting Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles, is also a critical aspect of the role. The Sr. CRA will develop recruitment plans with each site and manage enrollment to ensure that sites meet their enrollment milestones, documenting any recruitment barriers and mitigation plans. Additionally, the Sr. CRA is responsible for ensuring that monitoring KPIs are observed and remain within acceptable quality ranges, preparing and finalizing monitoring visit reports in the Clinical Trial Management System (CTMS), and ensuring timely collection and uploading of essential documents into the electronic Trial Master File (eTMF). In some countries, CRAs may also be accountable for study start-up and regulatory maintenance, which includes the collection, preparation, review, and tracking of documents for the application process, as well as submission to Ethics Committees/Institutional Review Boards (EC/IRB) and Regulatory Authorities. The Sr. CRA will collaborate with local Medical Affairs and other internal stakeholders as needed, follow quality issue processes, and prepare for audits and regulatory inspections in coordination with the Quality Group.
Responsibilities
- Perform selection, initiation, interim monitoring, and closeout visits (remote and onsite) according to the Clinical Monitoring Plan (CMP).
- Drive performance at the sites and proactively identify and resolve study-related issues, escalating as appropriate.
- Train, support, and advise Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.
- Develop recruitment plans with each site and manage enrollment to ensure sites meet enrollment milestones.
- Document recruitment barriers and mitigation plans.
- Ensure monitoring KPIs are observed and remain within acceptable quality ranges.
- Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to the Principal Investigator.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP and local requirements.
- Support/participate in regular QC checks of the eTMF.
- Accountable for study start-up and regulatory maintenance in some countries, including document collection and submission to EC/IRB and Regulatory Authorities.
- Contribute to the nomination and selection of potential investigators and assist with feasibility activities.
- Collaborate with local Medical Affairs and other internal stakeholders as needed.
- Follow quality issue processes by escalating systematic or serious quality issues to relevant parties.
- Prepare for and collaborate with activities associated with audits and regulatory inspections.
Requirements
- Minimum of 4 years 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 and 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 driver's license and clean driving record.
- Solid knowledge of clinical development processes with strong emphasis on monitoring.
Nice-to-haves
- 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.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Proactivity and assertiveness when communicating with internal stakeholders and sites.
- Ability to understand the impact of technology on projects and to use and develop computer skills 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.
Benefits
- Diversity and equality of opportunity in the workplace.
- Commitment to building an inclusive and diverse team.
- Compliance with all applicable laws and regulations on non-discrimination in employment.
