Summarized Purpose: Supports compliance to the clinical trial process. Helps ensure all study documentation and source data is captured accurately in eCRF, up to date and first time right. Assists with quality reviews and answers any eCRF queries for studies with low complexity in a timely manner.

Essential Functions

• Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed.

• Assists with data capturing activities on one or more studies. May provide support across multiple sites and/or regions.

• Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries.

• Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations.

• May assist monitors and sponsor representatives with query resolutions after monitoring visits. Escalates to management as needed.

• Learns 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.

Job Complexity

Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.

Job Knowledge

Applies acquired job skills and company policies and procedures to complete assigned tasks.

Supervision Received

Normally follows established procedures on routine work, requires instructions only on new assignments.

Business Relationships

Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Qualifications:

Education and Experience:

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 2 years).

Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.

• Occasional drives to site locations. Frequent travel both domestic and international.

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 of 15-20 lbs.

• 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.