Senior Clinical Research Associate

31404
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
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 country team(s). The Sr. CRA works in close collaboration with other CRAs and the Country Operations Management (COM) Team to ensure that study commitments are achieved in a timely and efficient manner. 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 (e.g. Lead CRA, etc).
You Will Be Responsible For

• 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
• 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).
• Contributing to the nomination and selection of potential investigators and assisting with feasibility activities
• Training, supporting, and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.
• Collaborating with local Medical Affairs and other internal stakeholders, as needed.
• 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.
• Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with SML and Quality Group.
• Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO and/or Quality Group as required.
• 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.
• 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.
• Driving performance at the sites. Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.

You Will Need To Have

• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good understanding of the drug development process.
• Good negotiation skills.
• Minimum of 4 years of CRA monitoring experience
• Excellent knowledge of relevant local regulations.
• Solid knowledge of clinical development processes with strong emphasis on monitoring
• Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
• Excellent attention to details.
• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
• Excellent written and verbal communication skills.
• Valid driver’s license and clean driving
• Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent collaboration and interpersonal skills.
• The duties of this role are generally conducted in a field environment. As is typical of a field-based role, employees must be able, with or without an accommodation to: travel by public transportation, automobile, train, or plane; work comfortably in a clinical setting; use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
• Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)

We Would Prefer For You To Have

• Experience in all study phases and in rare medical conditions preferred.
• 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.
• Proactivity and assertively when communicating with internal stakeholders and sites
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Ability to work in an environment of remote collaborators and in a matrix reporting structure
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• 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.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion's COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact [email protected]. Alexion participates in E-Verify.
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, and much more.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.