Data Compliance Coordinator

4 weeks ago

Somerset West, South Africa Thermo Fisher Scientific Full time

**At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Alongside clinical research through our PPD® clinical research portfolio, our work in **Accelerated Enrollment Solutions** optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on - now and in the future.**:
**Do you have a data entry and clinical research background? Are you interested in the dynamic clinical research industry?**

We are currently looking to recruit a Data Compliance Coordinator for our clinical site in Helderberg, South Africa.

**Key responsibilities for a Data Compliance Coordinator are as follows**:

- 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

**To be considered for this exciting opportunity you will require the following skills and experience**:

- Ability to multi-task and support multiples studies with a number of participants simultaneously
- Great attention to detail
- Ability to work in a multi cultural and dynamic environment
- Good MS Office and computer skills
- Ability to learn basic medical terminology

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**#AES #LI-TK2**:

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