Opening for Clinical Trial Assistant @ GVK Bio

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    Monitoring:

Assists in in-house activities of the PM/ CRAs as assigned.

Participates in internal teleconferences and prepares Minutes of Meetings on the projects as assigned.

Updates study and patient status information and serves as resource for the project team

Contacts Site staff as needed for critical information

Performs Routine Monitoring at sites. If required.

Attends / assists study team in Site Selection, Site Initiation and Site Close-out visits.

    Documentation:

Coordinates shipment of study related documents to the Sponsor after appropriately processing them as per the Sponsors standard operating procedures.

Shall be responsible for sorting the study related documents as per codes/ categories specified by Sponsor

Assists PM/ CRA in tracking the shipment and receipt of the study documents

    Administrative:

Coordinates shipment of Clinical Trial material including IP and study documents to sites

Assists in preparation for and attends Investigator Meetings as needed

Arranges for the receipt of administrative and regulatory documents from sites

    Clinical Supply Unit Functions:

Shipment receipt

Reviewing returned IP for damage/ tamper and completion of IP Return Shipment Form.

Reshipment of IP following a request from the PM/ CRA.

Maintenance of Project specific CSU files.



Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Clinical Research Associate/Scientist
Role: Clinical Research Associate/Scientist
Keyskills: Clinical Trial Coordinator, Clinical Research Coordinator, Study Coordinator, Clinical Trial Assistant, CTA, CRC,
Desired Profile

    Good Organizational Skills.
    Attention to detail.
    Ensuring successful and timely completion of all defined aspects of Clinical Studies (e.g. In-house monitoring, project tracking)
    Proven strength in problem resolving, coordination and analysis
    Multi-tasking: Prioritizing and multitasking to ensure that tasks are completed in time and Time Management.
    Teamwork: Effectively collaborates with team members
    Good judgment in triaging calls from Investigative sites
    Communication and Interpersonal skills


Education:UG -Any Graduate
PG - MBA/PGDM - Any Specialization, M.Sc - Any Specialization, M.Pharma - Pharmacy, PG Diploma - Any Specialization
Doctorate - Doctorate Not Required
Company Profile
GVK is today among India's leading transnational business conglomerates. GVK's areas of activity range from power and hospitality to biotechnology, manufacturing, finance, petrochemicals and infrastructure development. The diverse GVK enterprises are united by a common vision. GVK is dedicated to making positive contributions for a better future.
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