Senior CRA (UK)

Job title:

Senior CRA (UK)

Company

Bionical Emas

Job description

A Career with PurposeBionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world. We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.About the RoleWe are looking for a CRA II/ Senior CRA to perform and coordinate all clinical monitoring and site management activities. To act as the site manager, developing a working relationship with the assigned investigational sites and ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. To conduct remote and on-site visits and regularly contact sites to assess protocol and regulatory compliance and manage essential documents. To deliver within time, quality and budget, as per study plans, company and sponsor requirements. To ensure that sites are audit and inspection ready at all times.What will your job look like?

• Completes role-specific training, documents in learning management system, and adheres to Bionical Emas SOPs and policies
• Submits timesheets and expenses on time, attends departmental meetings, mentors CRAs, and contributes to process improvement initiatives
• Manages investigational sites from Start Up to Close-out, including site identification, feasibility, and selection
• Conducts Site Qualification Visits, prepares visit reports, and supports regulatory, ethics applications, and site agreements/budget negotiations
• Conducts and documents site initiation training, ensuring compliance with protocol, regulatory, and ICH GCP obligations
• Monitors study conduct through on-site and remote visits, ensuring data accuracy, site compliance, and resolving queries in the Electronic Data Capture system
• Manages investigational product shipping, storage, accountability, and ensures proper documentation of safety events
• Maintains regular contact with sites, identifies protocol deviations, implements corrective actions, and escalates issues to project leads
• Tracks study progress, updates study systems, supports site payments, and provides regular updates to clinical and project leads
• Ensures study closure by collecting all patient data, closing site actions, performing trial close-out visits, and finalizing drug reconciliation and site payments

What will you need to succeed?

• Bachelor’s degree in a life science related field or a registered nursing certification or equivalent and relevant formal academic / vocational qualification
• Must have previous independent monitoring experience in the UK

What will you get in return?We want you to do your best work! We care about our people’s well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.

• 25 days of vacation
• Vacation days purchasing scheme
• 1 extra vacation day per each 3 years of service
• Discretionary Annual Bonus
• Sabbatical of 3 to 6 months (after 2 years of service)
• Free food and beverages at all offices
• Life Insurance
• Health Insurance and Employee Assistance Programme
• Employee Support Networks – help us continue to build on our inclusive culture
• Flexible and hybrid work

Does this sound like you?It is time to apply, and we can’t wait to hear from you!Even if you don’t meet 100% of the requirements, be confident in yourself and don’t hesitate to apply!PLEASE NOTE: We will be longlisting applications as soon as we receive them, so please apply early to register your interest.We Are Bionical EmasWe are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances. Bionical Emas’ management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at .We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.Protecting your privacy and the security of your data is a longstanding top priority for us. Please consult our Privacy Notice to know more about how we collect, use, and transfer the personal data of our candidates. Our Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Bionical Emas’ use of your personal information. By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: applicable to your place of residence.Powering the patient journey

Expected salary

Location

Derby

Job date

Fri, 21 Jun 2024 01:48:26 GMT

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