Coordinates data and operational compliance activities on one or more studies to ensure successful delivery of the studies.
Ensures accurate and timely entry of all data in the CRF/data collection tool from the source data/ notes, and tracks the flow of the CRF’s, queries, and patient recruitment statuses; reports out the flow of data.
Prepares and collates regulatory documents for submission, including but not limited to site staff CVs, credentials, EC details, etc.
Participates in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
Contacts patients/ subjects to arrange and facilitation of their visits.
Maintains the ISF and study trackers as delegated.
Follows the QC process and checks that ICF’s are correctly completed.
Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
QCs all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and assessed by a physician within the appropriate timelines and flags any out of range values.
Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
Identifies quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses, if applicable.
Timely coverage of all assigned trainings.
Completes the assigned activities as part of any Patient Support Programs (PSP)
Assists with archiving procedures if required.
Interprets and adheres to company SOPs and policies and assists with input during the review process.
Adheres to the rules and regulations of ICH-GCP and other regulatory and ethical guidelines and data protection regulations.
Executes any activities in compliance with applicable SOPs, instructions, and principles.
Education and Experience
• University degree with life science background or equivalent and relevant formal academic/
• Previous experience that provides the knowledge, skills, and abilities to perform the job
(comparable to at least 1 year)
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities
• Good knowledge and practical aspects of implementation of ICH-GCP guidelines.
• Good working knowledge of Business English.
• Ability to communicate information and ideas so others will understand; with the ability to
listen to and understand information and ideas presented through spoken words and
• Basic medical terminology knowledge.
• Good time management and multitasking skills to coordinate several studies simultaneously
• Ability to access and use a variety of computer software developed both in-house and off-theshelf.
• Appropriate MS Office Skills.
• Good attention to detail.
• May interact with others, relating and gathering sensitive information. Interaction includes
• Works with guidance or reliance on oral or written instructions from management. May
require periods of intense concentration.
• Ability to perform under stress.
• Regular and consistent attendance.
Working Conditions and Environment
• Work is performed in an office/ site-office environment with exposure to electrical office
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