Clinical Trial Associate Jobs in Thiruvananthapuram - Clinipace Clinical Research Private Limited Technopark

Clinical Trial Associate

Clinipace Clinical Research Private Limited Technopark

Not disclosed

Expired

Posted: 04 May 18

Job Description

Job Title: Clinical Trial Associate

Company: Clinipace Clinical Research Private Limited

Location: Technopark, Trivandrum, India

Job Overview:

The Clinical Trial Associate will support and work closely with the global project team including internal and external customers and suppliers through all phases of the study. Duties may include coordination, or ADI Log maintenance, data entry, tracking, scanning, copying, creating, maintaining and QC of essential documents and Trial Master Files. Meets defined chargeability expectations for the position.

Brief description :

Assists with conduct of site feasibility and associated tracking.
Coordinates the distribution and collection of site start up packets and essential documents. Tracks appropriately.
Communicates project status and provides associated reports to the project team as appropriate.
Assists in the retrieval and resolution of issues with transmittals.
Scans and copies project documentation inclusive of, but not limited to, essential documents, CSAs, CRFs, and DCFs.
Reviews deliverable to ensure accuracy of content and materials copied.
May Support the project team in preparation of documentation for Regulatory and Ethical Submissions.
Organizes study documents and materials in compliance with Project and/or Sponsor SOPs as appropriate.
Archives study documentation and works with IT to return the TMF to sponsor, as directed.
Reports all document collection and tracking issues to SMS Team Lead and/or project team on a regular basis
Establishes the Trial Master File / eTMF in accordance with project, organisational and regulatory requirements.
Maintains the Trial Master File / e TMF as required by the study plans
Files according to Clinipace SOPs and/or Sponsor requirements along with Clinipace quality standards and adhere to 98% accuracy across the major files sections and the documents contained therein.
Forwards correspondence to sites, sponsors and project teams as needed.
Interfaces with vendors as required for a project.
Provides support to the team communicating process improvement suggestions as applicable.
Resolves administrative issues on behalf of the Project Manager.
Review and maintain study Outlook folders.
Maintains project server and portal where applicable
Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently
Assists with final site TMF review and Close Out Visit reconciliation packets. Communicate findings and provide packs to CRAs.
Other duties as assigned by SMS Team Lead or Project Manager/SMS Director and per project-specific requirements
Job Requirements:
Education
Healthcare or life science degree is a plus Equivalent relevant work experience considered.
Experience
Prior work experience preferred

Preferred Skills Required:

Strong English language written and verbal communication skills
Strong interpersonal skills
Team-oriented and a strong team player
Strong computer skills, including Microsoft Office
Interest in learning medical terminology
Exceptional attention to detail

Job Particulars

Role others

Education Any Graduate

Who can apply Freshers

Hiring Process Written-test

Employment TypeFull Time

Job Id417024

Job Category Others

Locality Address

State Kerala

Country India

About Company

Technopark is the IT hub of the State of Kerala and based in Trivandrum which can rightfully claim to be the knowledge capital of the region. Technopark provides world class, robust and failsafe physical, power and datacom infrastructure, offering a no compromise yet low cost enabling the environment for IT industry that is leveraged by its occupant companies for a competitive advantage.

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