Job Description

The Serbian office is growing and we are looking for a Senior Initiation Clinical Research Associate. In this global role you willperfrom SSU tasks for a variety of European countries.

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.

Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s),

resolving conflicts, determining appropriate follow up until receipt of final

approval.

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.

Promptly identify, use judgment and knowledge to address and resolve

or escalate, any site question and/or issue, including but not limited to:

potential issues or risks with site activation timelines, issues with patient

recruitment strategy, deficiencies in training, data quality or integrity,

study non-compliance, etc.

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

Work in a self-driven capacity, with limited need for oversight.

Proactively keep manager informed about work progress and any

issues.

Qualifications

Knowledge and Experience

Prior CRO experience preferred in Study Start-Up

Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

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.

Education

• Educated to degree level (biological science, pharmacy, or other health-related discipline)

Skills

Client focused approach to work.

Flexible attitude with respect to work assignments and new learning.

Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.

Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables.

Proven ability to work across cultures.

Ability to successfully work in a ('virtual') team environment.

Proficiency in English and great communication skills

Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

Holds a driver's license where required.

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.