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Clinical Research Coordinator II
2 months ago
As a pivotal member of the Clinical Operations team, you will contribute to the global execution of Phase I - IV clinical trials across diverse therapeutic areas.
Your role is essential in ensuring that all clinical studies adhere to established Standard Operating Procedures (SOPs), company policies, and regulatory standards, thereby delivering timely and high-quality clinical data that supports the global registration and commercialization of our innovative products.
Key Responsibilities:
- Assist in the initiation, management, and closure of clinical studies, providing support to the Biomarker and Bioanalytical Operations team.
- Track and compile study-specific information utilizing databases, spreadsheets, and various tools.
- Engage in the quality assurance process for data and documentation.
- Coordinate meeting logistics, prepare agendas, and assist in documenting meeting minutes.
- Collaborate with other departments as necessary to fulfill assigned tasks.
- Contribute to the development of documents and standard forms.
- Ensure compliance with established practices, policies, and regulatory requirements in your work.
- Work alongside cross-functional team members in the Oncology, Inflammation, and Virology therapeutic areas.
- Support sample reconciliation for ongoing clinical studies in partnership with BBOps Study leads, including periodic consent verification.
- Utilize the eTMF/Veeva system to assist with eTMF filing.
- Participate in oral presentations as required.
Qualifications:
We value diverse backgrounds and experiences. The following qualifications and skills are sought for this position:
- Advanced degree (MA/MS/PharmD/PhD) with relevant clinical or related experience in life sciences, or a Bachelor's degree (BA/BS/RN) with a minimum of one year of relevant work experience.
- Preferred knowledge of general clinical practices and business operations.
- Proficiency in Microsoft Word, PowerPoint, and Excel.
- Strong verbal, written, interpersonal, and presentation skills.
Additional Skills:
- Demonstrated ability to learn quickly and adapt to changing environments.
- Capacity to transition smoothly between projects and provide support where needed.
- Understanding of the biopharma industry and related business practices.
- Team-oriented mindset with a focus on collaboration.
- Strong analytical and organizational capabilities.
- Familiarity with FDA, EMA, and ICH guidelines, as well as Good Clinical Practice (GCP) is advantageous.
- Proficient in using basic office tools and software.
- Clear and concise communication skills.
- Able to thrive in a highly matrixed environment and manage multiple tasks effectively.
- Willingness to travel when necessary.
Collabera is a leading Global Digital Solutions Company, specializing in Software Engineering Solutions for the most innovative organizations in Engineering, Cloud, and Data/AI sectors. With a strong foundation in serving the engineering needs of prominent businesses across Technology, Financial Services, Telecom, and Healthcare, Collabera operates in 60 locations across 11 countries, serving 30% of the Fortune 500 and consistently exceeding industry growth rates.
