Job Title: Senior Clinical Research Associate
We are seeking a highly skilled and experienced clinical professional to lead our team in monitoring clinical trials.
Key Responsibilities:
* Conduct site qualification visits, ensuring adherence to SOPs, regulations, and ICH guidelines.
* Perform feasibility, site selection, and start-up activities, including leading submissions with sites.
* Negotiate site agreements and execute contracts with support from the project manager.
* Ensure protocol compliance during interim monitoring visits and verify participant source data and Investigational Product accountability.
Requirements:
* Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
* At least 3-4 years of experience in monitoring clinical trials in CRO, Pharmaceutical, and/or Biotechnology industry as a SCRA/CRA.
* Experience in managing early phase oncology trials is highly preferred.
* Experience in EDC & CTMS, contract negotiation, and submission preparation.
* Understanding and practical knowledge of ICH-GCP requirements.
* Willingness to travel for site visits and project meetings.
About Our Organization:
We are a dynamic team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes.
We offer a collaborative work environment and opportunities for growth and development.