Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job-related skills

Excellent technical/IT skills. Able to understand the impact of technology on studies andto use and develop computer skills while making appropriate use of client systems/software.Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelinesregarding clinical studiesAble to work independently as well as in a team.Professional attitude with good customer focus (internal and external)Time Management as safety notifications, eTMF etc. need to be done in a timely manner.

Job Responsibilities

Maintain up to date participating center’s information (including all contact details).Responsible for preparing the Investigator and Sponsor files (electronic and/or paper) with essential documents for the initiation of sites participating in clinical studies. Assist client study staff with maintaining the sponsor files during the life of the study. Responsible for archiving at the end of study in accordance with relevant client SOPs, policies, and local regulatory requirements.Provide administrative support/accelerate the preparation, collation, review, tracking and filing of all documentation required for regulatory and/or ethics committee submissions.Supporting the execution of Confidentiality Agreements, Conflict of Interest forms and collecting Data Privacy Notices. Administrative support for contracting.Provide administrative support for the management of investigator site payments, preparation of purchase orders, and/or preparation of task orders for services.Provide administrative support for oversight of vendor(s), managing local study material, clinical and ancillary supplies distribution, ordering, tracking, storage, and reconciliation.Support the development and maintenance of accurate tracking information related to site and supplier contracts, and external costs.Responsible for accuracy of relevant study systems.Setting up new employees and site staff on relevant systems and completing documentation.Planning, logistics and preparation of monthly reports, e.g., KPI reports, governance level 1 reports, financial reviews, etc.Planning, logistics and preparation of local Investigator meetings (travel arrangements, assist with preparation and distribution of study related presentation material etc.)Support in Informed Consent management (from template to final local version) working with trial manager.As an active participant of clinical study teams, engage in local study meetings during the life of the study to obtain general knowledge about the study and be responsible for given tasks.

Assist client study staff with study related activities such as:

organizing study meetings and scheduling travel,producing minutes for study-related meetings,assembling training and study materials,updating contact details,maintaining study documentation, including filing and review of eTMF,assisting in the preparation of documents and other tasks as required.Knowledgeable of client systems and the willingness and ability to continuously learn and become highly competent in using client’s evolving systems and tech.Keep up to date with all the changes/required knowledge on ICH GCP, client written standards and attending appropriate training sessions.May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.Requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community.Identifies issues and raises them to client study staff to take necessary corrective action to ensure smooth and rapid progress of studies.