Clinical Research Associate

Initial Therapeutics, Inc.; Thatcham; On-site; GBP 45,000 - 65,000; Full time

Job summary

AbbVie is seeking a skilled clinical research professional to advance patient-focused trials by partnering with investigators and site staff. You will drive site engagement, training, and monitoring to ensure compliant, high-quality data and strong patient outcomes across therapeutic areas.

As a primary contact for sites, you will implement risk-based monitoring, optimize patient recruitment, and mentor junior CRAs within a fast-paced environment.

Qualifications

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring.
• Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trials.
• Advanced knowledge of regulatory requirements (ICH/GCP) and related policies.
• Demonstrate strong cross-functional collaboration and planning skills.
• Ability to leverage technology and CRM tools to support site engagement and monitoring.

Responsibilities

• Primary point of contact for investigative sites with high engagement and coordination.
• Aligns and trains site staff on trial goals, protocol, and patient treatment principles.
• Performs site evaluation, training, routine monitoring and site closure activities per SOPs and regulations.
• Develops site engagement strategies using local insights and CRMs to report progress.
• Ensure recruitment strategies align with patient journey and protocol compliance.
• Mentor and train less experienced CRAs and participate in task forces as needed.
• Proactively monitor site performance and patient safety, reporting issues.
• Assess and mitigate site risk with preventive and corrective actions.
• Identify potential investigators/sites to support study placement.
• Ensure timely data submission and audit readiness at sites.

Skills

Clinical monitoring

Regulatory knowledge

Cross-functional collaboration

Planning & organization

Site engagement

Data integrity & quality

Critical thinking

Communication skills

Integrity & ethics

Mentoring & training

Education

Tertiary health qualification

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance.

Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials.

Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities :

• Considered as the primary point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVies positioning.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership
• Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
• Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator payments as per executed contract obligations, as applicable.

Qualifications

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. Familiar with riskbased monitoring approach, onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP
• Guidelines and applicable policies.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
• Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html