Company

Biotech

SeniorClinicalResearchAssociate

€70–95k ~AI est. Ireland FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“Senior Clinical Research Associate. Skills: Clinical trial methodology, Regulatory frameworks, ICH-GCP guidelines, Site management. Serve as primary point of contact. Ensure protocol adherence”

What You'll Achieve.

Improving patient care; Improving treatment outcomes

Industry & Context.

Biotech
Problems you'll solve

Problem-solving; Analytical

Eligibility Requirements

Willingness to travel extensively

What They're Looking For.

Must Have

Degree in biological sciences, Degree in pharmacy, Degree in nursing, Degree in health discipline, Equivalent professional experience, Ability to work independently, Manage priorities, Make sound decisions, Proficiency with clinical systems, Proficiency with CTMS, Proficiency with EDC, Proficiency with electronic document management tools, Proficiency with MS Office applications

Nice to Have

Experience in site management, Experience in clinical research, Understanding of clinical trial methodology, Understanding of regulatory frameworks, Understanding of ICH-GCP guidelines

What You'll Do.

Serve as primary point of contact

Ensure protocol adherence

Ensure operational compliance

Ensure high-quality study execution

Conduct remote contacts

Evaluate site performance

Support ongoing study activities

Build relationships with investigators

Build relationships with site staff

Provide training to sites

Provide guidance to sites

Provide ongoing support to sites

Monitor data integrity

Ensure data integrity

Address data quality concerns

Oversee site documentation

Ensure audit readiness

Ensure inspection readiness

Assess site recruitment strategies

Assess study progress

Assess site performance

Recommend corrective actions

Recommend improvements

Ensure ICH-GCP compliance

Ensure local regulations compliance

Ensure study-specific procedures compliance

How You'll Work.

Team & Collaboration

Internal teams; Clinical sites; Site teams; Global clinical teams

Communication Scope

Communication; Interpersonal

Full Job Description

## Accountabilities Serve as the primary point of contact for assigned clinical trial sites, ensuring protocol adherence, operational compliance, and high-quality study execution from initiation through close-out. Conduct site visits (qualification, initiation, monitoring, and close-out) as well as remote contacts to evaluate site performance, resolve issues, and support ongoing study activities. Build and maintain strong relationships with investigators and site staff while providing training, guidance, and ongoing support to ensure regulatory and procedural compliance. Monitor and ensure data integrity by reviewing CRFs, resolving queries, tracking SAEs, and addressing any data quality concerns in collaboration with site teams. Oversee site documentation, including regulatory files and TMF contributions, ensuring audit and inspection readiness at all times. Assess site recruitment strategies, study progress, and performance, recommending corrective actions and improvements where needed. Ensure compliance with ICH-GCP, local regulations, and study-specific procedures while identifying and escalating risks impacting timelines or data quality. Requirements: Solid experience in site management or clinical research, with strong understanding of clinical trial methodology, regulatory frameworks, and ICH-GCP guidelines. Degree in biological sciences, pharmacy, nursing, or a related health discipline, or equivalent professional experience. Strong ability to work independently, manage priorities, and make sound decisions in a fast-paced, matrixed environment. Excellent communication, interpersonal, and stakeholder management skills, with the ability to interact effectively with clinical sites and internal teams. Strong analytical, problem-solving, and attention-to-detail skills with a focus on data quality and compliance. Proficiency with clinical systems such as CTMS, EDC, and electronic document management tools, along with MS Office applications. Willingness to travel e

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