Company: inVentiv Health Clinical
Closing Date: 09 Feb 17
Salary (£): Negotiable
inVentiv Health -Transforming Promising Ideas into Commercial Reality Job Title: Clinical Trial Assistant (CTA) (ref. 5465) Primary Function: We are looking for new enthusiastic colleagues to join inVentiv Health. Working in our Strategic Resourcing department means that you will be fully employed by inVentiv Health, with full benefits while solely working for our client, one of the biggest healthcare companies in the world. ...
inVentiv Health -Transforming Promising Ideas into Commercial Reality
Clinical Trial Assistant (CTA) (ref. 5465)
We are looking for new enthusiastic colleagues to join inVentiv Health. Working in our Strategic Resourcing department means that you will be fully employed by inVentiv Health, with full benefits while solely working for our client, one of the biggest healthcare companies in the world.
As a CTA you will be providing administrative support to the Clinical Project Manager and clinical study team. In this position you will partially be home-based, also you will be working from our clients office in Beerse, Belgium.
* Pre- Study Activities - Study Site identification:
* Support the local study team in performing country and site feasibility
* Trial documentation:
* Prepare study files and prepare or co-ordinate the development of any other document required pre-trial
* Start- up activities - site start up:
* In liaison with the LTM, ensure that the current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site.
* Support the LTM or, where applicable, the SM in providing the current and complete copies of the documents that the IEC/IRB requests to fulfill its obligation.
* In liaison with the SM, obtain site related trial documents and review them for completeness and accuracy
* Distribute, collect and track IFDF throughout the trial
* Support the SM/LTM in collecting and processing as appropriate 1572 forms and related documents throughout the trial.
* Assist the LTM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting as applicable
* Distribute, collect, review, and track regulatory documents, agreements and training documentation
* Study execution activities Site management:
* Support the LTM in drug distribution process
* Support the LTM in ensuring that during the trial all relevant trial related documentation is provided to investigators and central IEC (if applicable) within the timelines.
* Support the LTM/SM in maintaining the study files
* Budget and resources: execute payments
* Provide administrative and logistic support to LTM/SM in tracking of progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate, where applicable
* Study Close-out activities - Site closure:
* Provide administrative and logistic support to the SM/ LTM in activities related to study/site closure, as appropriate, and follow up of all items identified, including but not limited to IFDFs one year post trial, where applicable
* Trial documentation:
* In liaison with the LTM ensure that appendix 1 documents are completed and forward them to the GTM CTA
* General activities:
* Represent the company and the organization adequately to the customers and other external parties
* Protect the rights of others, protect privacy and company assets, particularly information as the key asset
* Conduct business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind
* Report every company product related complaint you receive to the company, according to company policies.
* Maintain adequate communication with relevant parties within and outside the company
* Comply with ICH-GCP and all applicable local laws and regulations
* Actively follow trainings to ensure adequate qualification for performing job-related tasks
* Report (suspicion of) fraud or scientific/ethical misconduct as appropriate
* Regularly update information in applicable systems and templates
* Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company’s effort towards continuous quality improvement
* Maintain quality standards and timelines that are consistent with business needs
If you are the right candidate for this position, you are very welcome to send your CV with reference number 5465. We are looking forward to receive your application!
If this role is not suitable for your experience but you have worked in clinical research in the industry and would like to discuss other roles, please contact us as well for other possibilities!
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries.
We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market. For more information, visit inVentivHealth.com
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.