Initiation Clinical Research Associate
2 days ago
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 iCRA role offers the opportunity to go beyond the role of a typical clinical monitor. iCRA’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 iCRA, 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**:
- Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:oPreparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.oConduct remote Qualification Visits (QVs).
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
**Qualifications**:**
More about you**
On your first day we’ll expect you to have:
- Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
- Ability to perform all clinical monitoring activities independently.
- 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
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