# Clinical Functional Service Partnerships (CFSP)

**Company**: IQVIA
**Location**: Reading, Berkshire
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/Clinical-Research-Associate-II_R1577427?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_5a7c0932-a00

## Description

At IQVIA, our Clinical Functional Service Partnership (CFSP) model offers the best of both worlds: the variety and sponsor-level exposure of working as an embedded member of a leading pharmaceutical or biotechnology team, backed by the stability, global infrastructure, and career support of IQVIA.

You'll develop deep, specialist expertise on a dedicated program, with the flexibility to expand across sponsors and therapeutic areas as your career progresses - and the security of a long-term IQVIA career even as individual programs evolve.

Through our long-standing partnerships with the world's leading pharmaceutical and biotechnology companies, you'll contribute to clinical research programs that bring innovative treatments to patients worldwide, working across all phases of development and a broad range of therapeutic areas, within a culture that supports flexibility, continuous learning, and wellbeing.

**Key Responsibilities:**

- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, GCP, ICH guidelines, and applicable regulatory requirements.

- Ensure investigational sites maintain high standards of patient safety, data integrity, protocol compliance, and study quality.

- Build and maintain effective relationships with investigators and site personnel, providing ongoing guidance, training, and support throughout the study lifecycle.

- Monitor study progress, including regulatory documentation, patient recruitment and enrollment, data query resolution, and site performance metrics.

- Collaborate with sites to implement and optimize patient recruitment and retention strategies to support study timelines.

- Maintain accurate, complete, and inspection-ready study documentation, including Investigator Site Files (ISF), Trial Master Files (TMF), monitoring reports, and follow-up communications.

- Identify, assess, and appropriately escalate study risks, site issues, and quality concerns while driving timely resolution.

- Partner closely with cross-functional study teams to support successful study execution and delivery of project objectives.

- Mentor and support junior clinical team members through coaching, training, and co-monitoring activities, as applicable.

- Contribute to continuous improvement initiatives and support study start-up, maintenance, close-out, and site financial activities as required.

**What You'll Bring:**

- University degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related discipline, or equivalent combination of education and experience.

- 2 years minimum on-site monitoring experience of clinical trials within a CRO, pharmaceutical, biotechnology, or healthcare environment.

- Strong knowledge of GCP, ICH guidelines, and applicable regulatory requirements.

- Preferable experience in a sponsor-dedicated or cFSP environment.

- Knowledge of patient recruitment and study start-up activities is preferred.

- Excellent communication, organizational, and stakeholder management skills.

- Ability to work independently, manage multiple priorities, and collaborate effectively within cross-functional teams.

- Willingness to travel within the assigned region (up to 40-60% of working time).

**Please Note:** This position cannot offer visa sponsorship, candidates must hold right to work in UK & Ireland.

**Build Your Future with IQVIA:** As a Senior CRA at IQVIA, you'll apply your clinical research expertise to drive meaningful outcomes for patients and sponsors around the world. You'll work on innovative studies across a variety of therapeutic areas, collaborate with industry-leading professionals, and take on increasingly strategic responsibilities throughout the clinical trial lifecycle. With continuous professional development, global career opportunities, and a culture that values expertise and innovation, IQVIA provides the platform to elevate your career and make a lasting impact on healthcare.

## Skills

### Required
- GCP
- ICH guidelines
- Life Sciences
- Health Sciences
- Nursing
- Pharmacy

### Nice to have
- patient recruitment
- study start-up activities
- sponsor-dedicated or cFSP environment

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/Clinical-Research-Associate-II_R1577427?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)