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Clinical Research Associate
2 months ago
Position Overview:
As a Clinical Research Associate (CRA) at Planet Pharma, you will be an integral member of the Clinical Services Management team. Your role will involve supporting the Clinical Services Project Management Team through a diverse range of responsibilities associated with Sponsor's Monitoring Visits, including Study/site Qualification and Initiation Visits, Monitoring Visits, Closure Visits, and Ad hoc Visits, as well as Pharma Partner's audits. Your daily activities will encompass on-site administrative tasks to ensure that all monitoring visits and audit requests are executed efficiently and effectively.
Key Responsibilities:
The CRA is tasked with delivering specific activities, typically overseen by the Project and/or Program Managers. These tasks are time-sensitive and will be monitored closely. The CRA ensures that all activities are performed in accordance with the CDx CAP/CLIA Laboratory quality system. Collaboration with Quality, CDx CAP/CLIA Laboratory, and Pathologist is essential.
Responsibilities Include:
- Calendar Coordination: Manage schedules for SIV, Monitoring Visits, Closing Visits, and Audits.
- Documentation Management: Maintain and prepare laboratory and study documents for auditors, ensuring that Delegation of Authority (DOA) Logs are current, personnel are trained, and documentation practices are adhered to.
- Monitoring Visit Facilitation: Actively participate in and support monitoring visit activities.
- Supplier Questionnaire Management: Complete and manage supplier questionnaires, ensuring timely follow-up with Subject Matter Experts.
- Process Improvement Participation: Engage in initiatives aimed at enhancing operational efficiency.
- Additional Duties: Undertake other tasks as assigned by Clinical Services Management.
Qualifications:
Education: A Bachelor’s degree in life sciences, nursing, or a related field; Business Administration or equivalent experience is also acceptable.
Experience: A minimum of 2 years in administrative management, entry-level CRA, or CTA experience, preferably with a background in histotechnology laboratories.
Skills and Abilities:
- Excellent communication skills, proficient in English, both written and verbal; knowledge of additional languages is a plus.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and Google Tools.
- Strong organizational skills with the ability to manage multiple tasks effectively.
- A positive, energetic attitude with a proactive approach to challenges.
- Detail-oriented with a commitment to timely delivery of tasks.
- Ability to work independently as well as collaboratively within a team.
- Strong critical thinking and problem-solving capabilities.
- Customer and Project Manager service-oriented mindset.
- Ability to communicate effectively with various internal stakeholders in a professional manner.
Preferred Qualifications:
- Experience in cancer research.
- Familiarity with ICH-GCP guidelines related to clinical trials.
- Experience working in global environments.
