Clinical Operations Technical Assistant

Clinical Operations Technical Assistant

Job Title: Clinical Operations Technical Assistant
Contract Type: Contract
Location: Hampshire, England
Salary: Negotiable
Start Date: ASAP
Reference: HQ00061561_1504270783
Contact Name: Lois Clear
Contact Email:
Job Published: September 01, 2017 13:59

Job Description

Job Role:

To ensure that essential clinical study documentation within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards.

To provide administrative oversight and to ensure integrity and compliance to company SOPs and regulatory requirements of Investigator Initiated Studies.

To ensure local clinical operations is effectively supported with respect to system maintenance/reporting, point of contact for dealing with external submissions/questions directly or via team (where applicable)

To provide administrative support to the local Clinical Operation team.

Key Responsibilities:

- Clinical study document management

- Coordinator and point person for regulatory submissions/external questions

- General administration

- IIT coordination for country/cluster (when applicable)

Minimum Qualifications:

- Good documentation practices

- GCP knowledge

- Some level of knowledge of clinical research activities

- Excellent computer skills

- Experience with the quality and documentation requirements of Clinical Operations

- Manage multiple customers, possibly in several different countries

- Knowledge of Medical Terminology

- Fluent in English (orally and written)