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Clinical Research Associate I

2 weeks ago

Petaling Jaya, Malaysia Parexel Full time

Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction.

As a CRA at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people 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. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we’re looking for and see if you have the right mix.
- Innovative
- Problem-Solver
- Communicator
- Tech-Savvy
- Confident
- Independent

**Rewards**:

- **Global Impact**:
We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**:
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Collaboration**:

- **Freedom**:
The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**:
Opportunities to work on multiple accounts - never boring
- **Compensation**:
Competitive salaries and bonus structure based on individual metrics.

**Your time here**
At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out.

As a CRA, Parexel 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. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel could be your next home.

**What you’ll do**:

- Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
- Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
- Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.
- Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification.

**Qualifications**:**
More about you**
On your first day we’ll expect you to have:

- Previous relevant work experience (preferred).
- Ability to perform clinical monitoring activities under supervision from the COL/LM.
- Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.
- Strong interpersonal, written, and verbal communication skills within a matrixed team.
- Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
- A client-focused approach to work and flexible attitude with respect to assignments/new learning.
An honest and ethical work approach to promote the development of life changing treatments for patients.
- Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.
**A little about us**
Parexel 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 ev