Senior Clinical Research Associate - FSP

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Job description

*Job Description*

As a Senior Clinical Research Associate (SCRA) at Parexel FSP you will be joining a team with a wide variety of experiences and knowledge. We're looking for people like you who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

You will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on oncology studies that deliver real impact.

Parexel FSP will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers.

If impact, flexibility, and career development appeal to you, Parexel could be your next home.

*Position Purpose:*

The Senior Clinical Research Associate (SCRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

*Primary Duties:*

• Coordinates & manages various tasks to achieve Site Ready.

• Participates & provides inputs on site selection and validation activities.

• Performs remote and on-site monitoring & oversight activities using various tools.

• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records visit & non-visit contact reports.

• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

• Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and various other systems.

• Supports and/or leads audits/inspection activities as needed.

• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

*Qualifications*

• Minimum 4 years of direct site management & monitoring experience gained within bio/pharma/ or CRO required.

• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

• Fluent in local languages and English (verbal and written) and excellent communication skills.
•B.A./B.S. preferred with a strong emphasis in science and /or biology.

*A little about us*

Parexel FSP is proud to be a leading Clinical Research Organization with colleagues across the globe. As a member of our team, you'll get to know your coworkers on a personal level. Have a question? A clinical research leader, project team member, technology "super user" or collaborator are a phone call away. Our clinical research teams meet regularly to have discussions in an open environment, allowing our team members to share their expertise and promote learning within the team. Management supports and encourages career growth through consistent performance discussions and evaluations. Whether your interest is to progress into a more senior level CRA role, into line management, Quality, Project Leadership or a variety of other positions, Parexel prides itself on career opportunities for our employees.*Why Work at Parexel*

*There are pivotal moments in every career:* Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.