Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Supports compliance to the clinical trial process by ensuring all study documentation and source data is captured accurately in eCRF, up to date and first time right. Performs quality review and answers any eCRF queries for studies with low complexity in a timely manner. Reviews accuracy of the Investigator Site Files (ISF). Performs quality compliance checks and answers any CRF queries in a timely manner
Essential Functions and Other Job Information:
- Maintains ISF and study trackers as delegated and verifies that ICFs are correctly completed.
- Assists with data capturing activities on one or more studies across multiple sites and regions.
- Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries.
- Verifies protocol visit windows are correct according to the protocol requirements and reports deviations.
- Assists monitors and sponsor representatives with query resolutions after monitoring visits.
- Understands and adheres to company SOP and COP 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.
- Assists with drafting compliance reports.
- Assists archiving procedures as needed.
- Coordinates frequently with monitors and client representatives. Supports preparation of monitoring visit duties and to clarifies any expectations relating to CRFs.
- Supports audit preparation and audit readiness.
- Identifies and escalates common data errors and trends and may assist with CAPA and problem-solving methods.
Qualifications:
Education and Experience:
- Basic knowledge of documentation for clinical trials is essential
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
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:
- Basic knowledge of theory and techniques in the data and compliance field
- Basic knowledge of documentation for clinical trials is needed
- Ability to multi-task and support multiples studies with a number of participants simultaneously
- Knowledge of audit preparations and facilitations
- Good industry knowledge of quality compliance and GCP regulations
- Solid interpersonal skills and ability to work with all levels of the site
- Good working knowledge of Business English
- Basic MS Office and computer skills
- Ability to learn basic medical terminology
- Firm attention to detail
- Understanding of requirements and ability to maintain commercial and patient confidentiality
Management Role:
No management responsibility
Working Conditions and Environment:
- Work is performed in an office or clinical environment with exposure to electrical office equipment.
Physical Requirements:
- Frequently stationary for 4-6 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift as per EHS regulations.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- 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 sentences.
- May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
- Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.