Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate advancing AbbVie’s innovative medicines through site monitoring and clinical trial execution. Partnering with investigators and study teams to ensure compliance, patient safety, data integrity, and recruitment success.
Responsibilities:
- Advance AbbVie's clinical research pipeline by supporting clinical trials and translating science into medicine.
- Partner with study teams, internal R&D stakeholders, investigators, and site staff.
- Serve as the primary sponsor point of contact for investigative sites.
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles.
- Mentor and support junior CRAs on site management activities and clinical research work.
- Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring.
- Ensure trial conduct complies with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards.
- Develop and execute customized site engagement strategies; gather site insights and track strategy impact.
- Support recruitment and retention plans based on the patient disease journey.
- Participate in or lead global and local task forces and initiatives.
- Perform continuous risk assessment with the Central Monitoring team to identify study performance and patient safety issues.
- Resolve site risk signals and implement preventative and corrective action plans.
- Identify, evaluate, and recommend investigators and sites for clinical studies.
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up.
- Maintain audit and regulatory inspection readiness at assigned sites.
- Manage investigator payments according to contract obligations, where applicable.
Requirements:
- Minimum of 3 years of clinically related experience; 2 years preferably in independent clinical research monitoring of investigational drug or device trials.
- Appropriate tertiary qualification in a health-related discipline such as Medical, Scientific, Pharmacy, or Nursing is preferred, not required.
- Familiarity with risk-based monitoring and on-site/off-site monitoring.
- Knowledge of therapeutic-area indications and ability to apply scientific concepts to clinical trials.
- Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
- Advanced communication and cross-functional collaboration skills.
- Superior planning and organizational skills; ability to manage competing projects and deadlines.
- Ability to leverage technology, tools, and resources for customer-centric site support.
- Excellent written, verbal, active listening, and presentation skills.
- Ability to establish site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to independently apply functional expertise, critical thinking, and good judgment to clinical site issues.
- Integrity aligned with AbbVie’s code of business conduct and leadership values.
- Self-motivated approach focused on timely, quality outcomes in a fast-paced environment.
Benefits:
- Innovative work culture
- Professional development
- Paid time off: vacation, holidays, personal days, and volunteer days
- Employee stock purchase
- Wellness spending account
- Flexible health insurance
- Retirement savings programs
- Bonus plan
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