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