Clinical Research Associate II (CRA II) - Midlands in Letchworth Garden City

You will play a key role in supporting the successful delivery of clinical trials, taking ownership of day‐to‐day clinical monitoring and site management activities. Acting as the main point of contact for assigned investigational sites, you'll build positive, collaborative relationships and support sites to run studies in line with the approved protocol, ICH‐GCP, applicable regulations and SOPs, helping to protect participant safety and ensure high‐quality data. You will work closely with project teams to deliver studies on time, to high quality and within budget, while supporting sites to remain audit and inspection ready at all times.

What will your job look like?

• Assists in conducting investigational site identification, feasibility and selection.
• Performs Site Qualification Visit (SQV), delivers the visit report and supports with any follow up questions or actions.
• Supports with site start‐up activities, including preparation, submission and management of regulatory and ethics applications and site clinical trial agreement and budget negotiation.
• Completes and documents in the applicable learning management system all required study‐specific training and prepares site initiation training.
• Initiates investigational sites according to the relevant procedures defined in the monitoring plan and other applicable study plans, to ensure compliance with the protocol and regulatory and ICH GCP obligations.
• Conducts monitoring tasks onsite and/or remote in accordance with the approved monitoring plan.
• Ensures that all required study documentation and records are collected and filed in the Investigator Site File and in the TMF, according to ICH‐GCP and applicable regulations. Conducts on‐site file reviews as per project specifications.
• Ensures site identify, document and report safety events according to the protocol, study plans, ICH‐GCP and applicable regulations.
• Identifies protocol deviations and site process failures and implements corrective and preventive actions as required to bring the site into compliance.
• Escalates observed deficiencies and issues to the clinical and/or project lead and follows all issues through to resolution.
• Provides regular progress updates on study progress to the study clinical and/or project lead, as required.
• Supports with site payments.
• Reviews and approves site visit reports.
• Performs trial close‐out visit and retrieval and/destruction of trial materials.
• Performs a final check of the Investigator Site File and TMF to ensure all required documentation is filed.
• Performs final drug reconciliation and return or destruction, as per study and site requirements.

What will you need to succeed?

• Bachelor's degree in a life science related field or a registered nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year as a clinical research monitor).
• Understanding of the Principles of Good Clinical Practice (GCP) and clinical trials regulation and able to demonstrate practical application.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient to meet the requirements of the role.

What we offer you in return?

• 25 days of vacation
• Vacation days purchasing scheme
• 1 extra vacation day per each 3 years of service
• Discretionary Annual Bonus
• Sabbatical of 3 to 6 months (after 3 years of service)
• 1 volunteer day per year
• Free food and beverages at all offices
• Life Insurance
• Health Insurance and Employee Assistance Programme
• Network Groups
• Flexible and hybrid work
• Training and Personal Development Allowance

Our Commitment to Inclusion and Diversity

We actively seek and hire individuals with diverse backgrounds, voices, beliefs and perspectives. We celebrate each individual's uniqueness and believe that diverse viewpoints fuel innovation and drive excellence. Our managers uphold an inclusive environment in hiring, promotion, training and benefits.

Equal Opportunity & Accessibility

Evestia Clinical is an equal opportunity employer committed to diversity in the workplace. We ensure fair treatment of all applicants and employees, without discrimination based on actual or perceived race, color, creed, religion, national origin, age, sex, gender identity or expression, sexual orientation, disability, veteran status or any other characteristic protected by applicable law.

We are committed to providing accessibility accommodations to applicants with physical and/or mental disabilities. If you require an accommodation or special assistance during the application process, please notify our recruitment team by sending an email with your request to HR@evestiaclinical.com.