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Senior Clinical Research Associate

4 months ago

Derby, United Kingdom Bionical Emas Full time

**A Career with Purpose**

Bionical 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 Role**

We have an opportunity for a Senior Clinical Research Associate (CRA) to join our exciting Clinical Development (CD) division UK team. The Senior CRA will be responsible for conducting the clinical monitoring of studies across our portfolio of work, including all visits from qualification through to close-out, alongside the management of clinical trial sites. You will be a skilled, proactive communicator, able to work with sites and colleagues to problem solve effectively. If you are someone who wants to be part of our company’s vision of bringing life-changing medicines to patients - keep reading for more information

**What will your job look like?**
- You will manage assigned investigational sites from Pre-study to Close-out, including On-site, Remote, Centralized/ Risk Based Monitoring (RBM) and/or a Hybrid monitoring format
- Assist the startup team in conducting Study Start up activities to include Site Identification, Site Feasibility and Site Selection, as required
- Manage and account for Investigational Product (IP/study drug/device) shipping, receipt, and storage at assigned sites
- Conduct Source Document Review (SDR) and Source Document Verification (SDV) & Compose/Resolve queries in the Electronic Data Capture (EDC) system with the Site Staff, working closely with the Bionical Emas Data Management (DM) department
- Managing investigational sites and site related activities on a day to day basis, ensuring timely, effective communication with investigational sites, within project teams, with Bionical Emas and, as appropriate, with Client
- May assist Line Manager(s) in conducting Accompanied Field Visits for new/junior CRAs
- Have the opportunity to serve as Mentor/buddy to new/junior CRAs
- Essential Document Management, including collect & review of Essential Documents from assigned study sites and upload to Electronic Trial Master File (eTMF) & manage the content of project site-level (e)Trial Master Files and ensure accuracy and completeness
- Frequent Travel to/from sites for visits, in line with the project plan requirements will be an expectation of the role

**What will you need to succeed?**
- University Graduate or appropriate level of education and experience; health care professional preferred; higher degree is desirable
- Previous experience of independent monitoring as a CRA is essential
- Clear and Effective Communicator
- Equally adept at working independently and collaborating with colleague
- Strong proficiency in relevant systems & software (Office, eTMF, CTMS etc)

**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

**We Are Bionical Emas**

**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.

**Powering the patient journey