Senior Clinical Research Associate - Fsp

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.
Parexel FSP currently has openings for Senior Clinical Research Associates (SCRA) in South Africa. Single sponsor dedicated. Great Pay &
Benefits.
As aSenior 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 for allocated sites.
**Primary Duties**:
- Coordinates &
manages various tasks to achieve Site Ready.
- Participates &
provides inputs on siteselection 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.
- Communicate 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.
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 differ