As you develop your career as a Senior CRA or CRA, this role offers you the opportunity to plan and progress your career in the direction you choose. At IQVIA, we do not believe in a ‘career ceiling.’ You will be exposed to wider opportunities like operations management, dedicated customer solutions, project management and more. And you won’t do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion opportunities and awards. Joining IQVIA will give you access to cutting-edge in-house technology and provide opportunities to work on global projects/ trials. You will be building a flexible, meaningful and fulfilling career with no limits.

Your responsibilities will include:

• Performing site selection, initiation, monitoring, and close-out visits, plus maintaining appropriate documentation

• Supporting the development of a subject recruitment plan

• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.

• Prepare site regulatory documents, reviewing for completeness and accuracy.

• Review, prepare and negotiate site contracts and budgets with sites, if applicable.

• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

• Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed.

• Establishing regular lines of communication plus administering protocol and related study training to assigned sites

• Evaluating the quality and integrity of site practices – escalating quality issues as appropriate

• Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

• May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.

• May participate in feasibility and/or site identification activities.

• May perform Site Selection Visits

• You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.

Qualifications:

• University degree in scientific discipline or healthcare

• At least 2 year of on-site monitoring experience and regulatory start-up experience

• Budget and contract negotiation experience

• Good knowledge of GCP and clinical research regulatory requirements

• Good computer skills including MS Office

• Excellent command of English language

• Organizational, time management and problem-solving skills

• Ability to establish and maintain effective working relationships with colleagues, managers, and customers.

• Flexibility to travel.

What you can expect:

• Working with different customers on global trials

• Career development opportunities for those who are passionate in wanting to grow as part of the organization.

• Leaders that support flexible work schedules/arrangement

• Excellent working environment in a stable, international, reputable company

• Programs to help you build your technical skills, therapeutic knowledge and regular refreshers for updates in the regulatory landscape

• Attractive remuneration package.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.