Data Compliance Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

*This is a great opportunity for an individual that has gained some experience working in a clinical or hospital environment or has gained some experience in data entry looking to move into a research based environment*

Day to day responsibilities:

• 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

Qualifications:

Education and Experience:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company (“PPD”), collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.

Knowledge, Skills and Abilities:

• Experience gained working in a clinical/ hospital environment with an interest to pursue data compliance OR has some data experience gained within another regulated environment

• Ability to multi-task and support multiples studies with a number of participants simultaneously

• Good interpersonal skills

• Good working knowledge of Business English

• Basic MS Office and computer skills

• Ability to learn basic medical terminology

• Good attention to detail

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