Clinical Research Associate (Exeltis In-house CRO)

COMPANY OVERVIEW, CULTURE, AND ENVIRONMENT

We are launching a globally focused internal CRO to deliver exceptional Clinical Trials results.

We are a high-growth, rapidly evolving, lean organization that prides itself on its fast-paced entrepreneurial style and rewards teamwork, collaboration, and resourcefulness. At our group there is great value placed on accountability and proactive problem-solving to meet timelines and objectives.

The Group CRO is looking to build a team of talented, qualified, and passionate individuals. The organization values diversity, collaboration, and creativity and cultivates a supportive, inclusive workplace, fostering employee growth and development.

POSITION OVERVIEW

The Clinical Research Associate (CRA) will play a vital role in the successful execution of

clinical trials. This role is responsible for ensuring that all site-level activities related to the study

implementation are performed in accordance with the protocol, applicable regulatory requirements, Good Clinical Practice (GCP) guidelines, and the company’s standard operating procedures (SOPs).

KEY RESPONSIBILITIES

• Study and Protocol Design and Planning
• Participate in the review of the draft protocol and provide feedback to medical writers and

clinical operations teams

consent forms, study manuals, and case report forms.

sub-investigators through mutual respect as well as study-specific and general clinical trials

expertise

leadership team.

risks in meeting study milestones

retention plans

o Ensure patient recruitment materials and budget are approved by the appropriate

stakeholders

o Work with sites to ensure an aggressive approach to identifying and prescreening

patients

conducted in compliance with the protocol, regulatory requirements, and GCP guidelines.

necessary to ensure timely resolution.

adverse events (SAEs), and proactively support the PI and site staff to gather required data

and reporting to minimize project impact.

compliance with the protocol and applicable regulations.

documentation, site visit reports, monitoring reports, and other study-related documentation.

procedures.

Additional Responsibilities may include :

Meetings

QUALIFICATIONS