Clinical Research Associate

Role overview

The Clinical Research Associate will own site-level study execution for assigned locations and take an active role in local study teams. This position partners closely with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistants, and other Clinical Operations colleagues to keep study commitments moving on time and to quality standards. The CRA serves as the primary liaison for the site and is accountable for overseeing study conduct, monitoring compliance, and ensuring delivery.

The role covers site identification, selection, initiation, monitoring, and closeout for clinical studies in line with company procedures, ICH-GCP, and applicable local rules. Depending on experience, the CRA may also handle additional study-level duties such as lead CRA responsibilities.

Key responsibilities

• Carry out site identification, selection, initiation, monitoring, remote and onsite visit activities, closeout, and remote data verification within the timelines defined in the study monitoring plan.
• Improve site performance by spotting study issues early and driving them to resolution, escalating when necessary.
• Coach, support, and guide investigators and site personnel on study matters, including Risk Based Quality Management concepts.
• Build recruitment plans with each site and support enrollment so that targets and milestones are achieved; record barriers and help implement corrective actions.
• Track monitoring KPIs and ensure they remain within approved quality thresholds, including aging metrics, source data verification, data entry, query aging, and monitoring visit report metrics.
• Draft and complete monitoring visit reports in CTMS and provide prompt follow-up communication to the Principal Investigator, including follow-up letters, within required timelines and SOP standards.
• Make sure essential documents are collected and uploaded to the eTMF on time and in line with ICH-GCP, internal SOPs, and local requirements; support regular eTMF quality checks.
• Where required by country, support study start-up and regulatory maintenance activities, including document preparation, review, tracking, and submissions to ethics committees/IRBs and regulatory authorities.
• Help identify and nominate potential investigators and contribute to feasibility work.
• Work with local Medical Affairs, Medical Advisor Pipeline, and other internal stakeholders as needed.
• Escalate systemic or serious quality concerns, privacy incidents, or ICH-GCP compliance issues to the appropriate study, operational, or quality stakeholders.
• Prepare for and support audits and regulatory inspections together with other local team members.

Requirements

• At least 1 year of experience in CRA monitoring.
• Bachelor’s degree in a relevant field, preferably life sciences, or an equivalent qualification.
• Strong knowledge of ICH-GCP and basic understanding of GMP/GDP.
• Solid understanding of local regulations relevant to clinical research.
• Good medical knowledge and the ability to quickly learn the company’s therapeutic areas.
• Clear understanding of clinical study management, including monitoring, investigational product handling, and data management.
• Excellent attention to detail.
• Strong written and spoken communication skills.
• Good collaboration, interpersonal, and negotiation skills.
• Willingness to travel and work flexibly; travel may reach 70% during busy periods.
• Valid driving licence.
• Comfortable working in an office-based setup with regular computer use, phone/video communication, problem solving, collaboration, and standard business-hour availability.

Preferred qualifications

• Experience working with remote colleagues and within a matrix reporting structure.
• Positive, adaptable approach to change and continuous improvement.
• Interest in improving trial delivery through more efficient and effective processes with lower cost and shorter timelines.
• Ability to juggle multiple priorities and deadlines.
• Confident and proactive communication with internal stakeholders and site teams.
• Comfort with technology, computer systems, and e-enabled project environments.
• Team-oriented, flexible, and responsive to changing demands.
• Experience across all study phases and in rare disease areas is an advantage.

Additional information

The role is expected to be conducted primarily in an office environment, with the usual requirements of an office-based position. Candidates must be able, with or without accommodation, to use a computer; communicate by phone, video, and electronic messaging; solve problems and engage in analysis and discussion; collaborate with others; and remain generally available during standard business hours.

Equal opportunity statement

The employer is committed to a diverse, inclusive, and equitable workplace. Applications are welcomed from all qualified candidates, regardless of background or protected characteristics, in line with applicable employment and non-discrimination laws and work authorization requirements.