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The position of Clinical Research Associate II (CRA II) at AbbVie focuses on advancing the company's pipeline in oncology by delivering excellence in clinical research. The core mission of this role is to translate scientific innovations into effective medicines for patients. The CRA II will engage with clinical trial sites and investigators, ensuring proper trial conduct while improving data integrity, compliance, and overall study performance.
The CRA II will be the primary contact for investigative sites, demonstrating a high level of competency in providing essential information related to clinical trials. Responsibilities include:
Building relationships with stakeholders and site staff to ensure effective engagements, thereby establishing AbbVie as the preferred sponsor in clinical trials.
Aligning, training, and motivating site staff and principal investigators regarding the goals of clinical trial programs and patient treatment principles, fostering a trusted partnership.
Conducting site evaluations, training, routine monitoring, and site closure activities according to the protocol and monitoring plans, ensuring compliance with applicable regulations and Good Clinical Practices (GCPs).
Gathering insights and utilizing site engagement tools like CRM to track and report progress, and developing recruitment strategies based on patient journeys.
Mentoring and training less experienced CRAs, and actively participating in global/local task forces.
Conducting continuous risk assessments in collaboration with the Central Monitoring team to ensure early detection of study performance issues.
Ensuring the quality of data from sites, timely submissions, and audit readiness, while managing investigator payments as per contracts.
To qualify for this position, candidates should possess:
A minimum of 1 year of clinically related experience, with at least 6 months in clinical research monitoring of investigational trials.
Familiarity with risk-based monitoring and clinical research regulations.
Relevant tertiary qualifications in health-related disciplines are preferred, particularly in oncology.
Experience as a study coordinator is advantageous.
Strong planning, organizational, and cross-functional collaboration skills to work dynamically in environments with competing projects.
Excellent interpersonal skills, including written and verbal communication abilities, to build relationships with stakeholders effectively.
While not mandatory, the following qualifications are beneficial for applicants:
Advanced knowledge of emerging regulatory requirements and ICH/GCP guidelines.
Experience in applying scientific concepts relevant to clinical trial execution, especially in oncology.
Demonstrated integrity and alignment with AbbVie’s code of conduct and leadership values.
Self-motivated professionals who can deliver quality outcomes quickly are preferred.
This role offers a comprehensive benefits package, which includes:
Paid time off (vacation, holidays, and sick leave).
Medical, dental, and vision insurance.
401(k) plan for eligible employees.
This job participates in short-term and long-term incentive programs, with compensation dependent on geographic location and individual qualifications.
AbbVie maintains the right to modify the highlighted pay range in the future based on various factors.
AbbVie is committed to operating with integrity and advancing innovation. Their mission is to discover and deliver innovative medications addressing serious health issues, thereby transforming lives, particularly in key therapeutic areas such as immunology, neuroscience, oncology, eye care, and their Allergan Aesthetics portfolio. AbbVie emphasizes the importance of equal opportunities, maintaining an inclusive environment for employees, veterans, and people with disabilities. They strive to create a remarkable impact on the health and well-being of individuals.
For applicants interested in this position, it is important to note that AbbVie complies with equal employment opportunity legislation, ensuring a fair recruitment process. Prospective candidates who require reasonable accommodations in the application process are encouraged to engage with the company to facilitate such needs.
In summary, the CRA II role at AbbVie offers the opportunity to engage meaningfully in the clinical research field, working on groundbreaking oncology trials while contributing to patient care improvements.
This job offer was originally published on himalayas.app
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