- Under the direction of Clinical Research Associate director, this individual is responsible for providing in house support and assistance to assigned Study Teams and management staff.
- The CCTA will provide support to the Study Team during start-up, maintenance and close-out of clinical studies.
Responsibilities include, but are not limited to:
- Fulfill all responsibilities in accordance with company SOPs / WPs and policies.
- Develop and maintain a good working knowledge of FDA, ICH/GCP requirements and relevant local regulatory requirements.
- Participate in and contribute to Clinical Research meetings, study related meetings, training activities and crossfunctional activities as appropriate
- Contribute to general departmental administration and the development and continuous improvement of departmental procedures.
- Maintain and facilitate effective and productive communication and working relationships with all members of the department and staff in other functions.
- Take personal responsibility for the quality of work, meeting required quality and performance standards and completing all assigned tasks in the most efficient and effective manner.
- Conduct additional tasks as may be required from time to time by the Clinical Research Director/Clinical Research Manager.
- Keep company Tracking databases up to date and enter study information into National Clinical Trial Database where appropriate.
- Design and maintain contracts & administrative tracking tools.
- Support the production, coordination, completeness and accuracy of EC submissions in order to guarantee company studies are submitted and approved in a timely fashion (for studies monitored in house).
- Customize contracts to local requirements as applicable.
- Support/Perform Research Contract negotiations (in English & local language, where appropriate) with Hospital/Institution, Central Contracts & Out-Sourcing Group, and company’s Legal Group, to ensure local Start Up timelines are adhered to.
- Track Site payments to ensure timely payments are reflective of the contract’s schedule.
- Support Clinical Team (e.g. office or home based, and the contract CRAs) in administrative tasks and logistical support related to R&D Studies.
- Manage study material and study supplies, as applicable.
- File and maintain the study administrative files locally and send original documents to central TMF. When applicable, ensure electronic filing.
- Organize local Investigator Meetings, including agendas and minute production.
- Liaise closely with the CRAs, Study Managers team and CTAs.
- May conduct data query resolution and SAE information collection via facsimile, mail and telephone.
- Manage local translators & printers for required local documents.
- Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute of communications and study documents to study teams.
- These might be single documents or packages and may be safety [submissions, safety letters (SUSARs), Investigator´s Brochures, or Annual Safety Reports] or study (listings, trackers, essential TMF documents) related.
- Participate in SOP and WP development and contribute to process initiatives as required
- Mentor and coach other CCTAs, as appropriate.
- Produce regular and adhoc Clinical Operations status reports as required.
- Perform all other related duties as assigned.
- Compliance with Quality and Environment Policies.
- Act according the Manual of Good environmental practices and segregate waste materials of the job properly.
Educational Background and Complementary Experience
- Degree in administration or relevant education or comparable operating experience.
- Advance in written and spoken English.
- Computer Literature: Good Knowledge at user level of Microsoft Office.
- Proficiency in Microsoft applications: Outlook, Word, Excel, etc.
- Good database and data manipulation skills/ knowledge.
- Knowledge of ICH / GCP and regulatory guidelines/directives.
1+ year experience as a clinical Trial Administrator or in a Clinical Research & Development.