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Clinical Research Associate
3 weeks ago
Overview:
In Pharmaceutical Research Associates, Inc, we are seeking a highly skilled Clinical Research Associate to lead our oncology trials with high-quality execution. As a key member of our team, you will oversee multiple trials, providing leadership and mentorship to junior colleagues.
Responsibilities:
- Diverse roles: Oversee the execution of various clinical trials in the oncology field, ensuring timely completion and meeting the set objectives.
- Team leadership: Provide guidance and support to junior team members, helping them develop essential skills for clinical research coordination.
- Protocol expertise: Act as a subject matter expert on study protocols, training and guiding other team members on best practices.
- Document development: Create study start-up documents, including SIV agendas, to ensure seamless trial initiation.
- Representative role: Represent the team's perspective in critical meetings, such as contract negotiations and site management discussions.
- Compliance monitoring: Review reports (SQV, SMV, SCV) for assigned sites, maintaining compliance with Metrics/KPIs outlined in the Quality Oversight Plan (QOP).
Qualifications:
- Educational background: Hold a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences.
- Experience: Possess at least 2 years of experience in monitoring clinical trials within the pharmaceutical industry.
- Therapeutic area expertise: Have experience in multiple therapeutic areas, particularly in oncology (Hematology, Prostate Cancer, Lung Cancer, Early Development - Phase 1).
- Risk-based monitoring: Knowledge of risk-based/analytical monitoring approaches is an asset.
- Clinical trial systems: Proficiency in clinical trial systems such as CTMS, EDC, TMF, IWRS, and safety reporting tools.
- Patient recruitment: Ability to drive patient recruitment strategies effectively at assigned sites.
- Communication skills: Strong communication and influencing skills to manage study sites effectively, both remotely and in-person.
- Independence: Ability to work independently while being a strong collaborator.
- Regulatory knowledge: In-depth understanding of Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.
Benefits:
We offer a range of benefits designed to promote well-being and work-life balance, including:
- Varying annual leave entitlements
- Range of health insurance options
- Competitive retirement planning offerings
- Global Employee Assistance Programme
- Life assurance
- Flexible country-specific optional benefits
At ICON:
We value diversity, inclusion & belonging as fundamental to our culture and values. Our diverse workforce enables us to better serve our people, patients, customers, and communities. We are committed to providing an inclusive and accessible environment for all candidates and employees.
