key responsibilities:
1. trial architecture:
> contribute to the development of dynamic trial plans and protocols in tandem with the clinical operations team.
> collaborate on the strategic selection and qualification of investigative sites.
2. site symphony:
> conduct harmonious site initiation, monitoring, and close-out visits to ensure seamless protocol execution and pristine data collection.
> cultivate collaborative relationships with investigative site teams, providing support and guidance.
3. regulatory mastery:
> ensure meticulous adherence to regulatory standards, guidelines, and the principles of good clinical practice (gcp).
> spearhead the preparation and submission of regulatory documents to ethics committees and regulatory authorities.
4. data choreography:
> direct the orchestration of data collection, ensuring the accuracy and completeness of clinical trial data.
> collaborate with data management teams to resolve data discrepancies and maintain a symphony of data quality.
5. risk ballet:
> proactively identify potential risks to trial success and choreograph mitigation strategies in collaboration with project teams.
6. communication sonata:
> cultivate clear and resonant communication channels with internal and external stakeholders.
> compose eloquent and timely study progress reports, fostering transparency and accountability.
qualifications:
bachelor's or advanced degree in a relevant field (life sciences, nursing, etc.).
demonstrated experience as a clinical research associate, preferably in the pharmaceutical or biotechnology domain.
profound knowledge of clinical trial processes, regulatory requirements, and gcp.
exceptional interpersonal and communication finesse