(Study Start-up) Initiation Clinical Research

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.
- **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 is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

**Due to a growing portfolio, we are currently looking for (Study Start Up) Initiation Clinical Research Associates to join the team in Italy. In this role you will act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. This role specialises in Pre SIV activities /start up tasks of the study.**
- Start-Up (from site identification through pre-initiation)
- 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 prequalification and qualification activities, which may include:

- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct 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.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:

- IRB/IEC and MoH / RA submission/approval, Site activation,
- Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
- Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
- Conduct remote visits/contacts as requested/needed.
- Assess & manage test article/study supply including supply, accountability and destruction/return status.

**Qualifications**:
**Knowledge and Experience**:

- Able to cover the following Study Start Up (SSU) tasks: ICF customization and Site facing activities (SRP doc collection, interaction with investigators and site departments for site activation)
- 1-1.5 years of experience minimum required
- Educated to degree level within a science discipline required
- Ideally coming from another international CRO
- Must live close to Mila