Job Description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at GCO Associate I (iCRA) , home-based and sponsor dedicated, in Spain, Israel and Poland

GCO Associate provides hands-on operational support for country and site clinical trial activities across study start-up or conduct and close-out, based on business needs and role scope.

The role interacts closely with local/regional clinical teams, internal Pfizer stakeholders, investigator sites, and external partners to support smooth operational workflows in compliance with ICH/GCP, SOPs, and local regulatory requirements.

We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.

As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.

You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

JOB RESPONSIBILITIES

Country & Site Operational Support

• Execute operational tasks across start-up, conduct and close-out phases.

• Maintain and update trackers, timelines, or task status to support visibility of progress and risks.

• Assist with follow-up on outstanding country or site deliverables and escalate gaps or delays to responsible leads as required.

• Could support coordination with local vendors and CROs by tracking deliverables and ensuring required documentation is received and filed.

• Undertake periodic review of study and site files for completeness and assist with reconciliation activities.

• Maintain site-facing communications, as applicable, to complete assigned work activities.

• Demonstrate a proactive approach to ongoing improvement by consistently seeking opportunities to enhance processes and optimise workflows.

Site Activation Support

• Interactions with sites for collection of documentation needed for Institutional Review Board (IRB), Local Ethics Committee (LEC), Regulatory Authority (RA) submission and Investigator Initiation Packages (IIP) Updates preparation as per country requirements.

• Responsible for preparation of Institutional Review Board (IRB)/Local Ethics Committee (LEC) clinical trial applications by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps.

• Submission to local Regulatory Agency where required.

• Responsible for preparation of Update to Investigator Initiation Packages (IIP) and essential documents by pre-populating documents, locating required records from systems (e.g., PTMF), and supporting processing through approval steps. Support filing of documents in PTMF, eISF, and document exchange portals, ensuring completeness and correct placement.

• Verify training, financial disclosure, and other required documentation in systems and upload documents received from sites, as applicable.

• Maintain site-facing communications, as applicable, to complete assigned work activities.

Site Contracting Support

• Provide operational support to site contracting activities, including, but not limited to, site contract and budget preparation, site-facing negotiation, status tracking, and the coordination of workflows required for site contract finalization, execution and filing.

• Maintain site-facing communications from document preparation through the execution and filing of site contracts.

• Responsible for maintaining accuracy and completeness of site contracting systems and related trackers (as applicable) for assigned work.

We expect from you

Education

• BS/BA or bachelor’s degree in life sciences or a related discipline is an asset.

Experience

• 2-5 years of relevant experience in clinical trial support, site activation, or clinical operations (pharmaceutical company or CRO).

• Exposure to country or site-level clinical trial operations and supporting documentation workflows.

• Experience supporting contracting, regulatory, or vendor-related documentation processes is an advantage.
  

Skills

• Effective written and verbal communication skills for interacting with internal teams and external partners.

• Ability to work effectively in a matrix environment and follow direction while collaborating across functions.

• Languages: Must be fluent in English and local language (requirements apply by country); additional languages are an asset.

We will offer you

• Premium salary.

• Attractive benefits.

• Medical care plan: Health, Dental & Vision.

• Life Assurance.

• Excellent work environment.

• Culture of teamwork and collaboration.

• People who motivate and face challenges together.

• Innovative technology.

• Excellent training.

For an immediate interview, please contact marta.kuniewicz@parexel.com