Compliance Coordinator

Overview:
**Job Description - Compliance Co-ordinator**

**Company**

Adelphi Research, part of Adelphi Group (an Omnicom Healthcare Company)

**About Adelphi Research**

Adelphi Research is a leading market research-based consultancy with a focus purely on the pharmaceutical and healthcare sectors. For over 25 years, we have partnered with most of the world’s leading Pharmaceutical Companies to design and deliver research solutions that generate meaningful insights and inspire commercial decision making

From our HQ offices in the UK and USA, we provide global research coverage, with the majority of our projects being multi-country in nature, including a mix of Western Europe and the Nordics, North America, South America, Australia, China and Japan. We are increasingly delivering research projects with coverage of the Middle East, Eastern European and Russia.

**Background on Compliance**

International healthcare market research is an increasingly complex area. There are numerous regulations and guidelines, which are country specific and which continually change. It is important to keep abreast of this complex, demanding and fast-changing compliance environment. Legislation which impinges on market research is growing and there are substantial penalties for non-compliance, both for Adelphi and our clients. Pharmaceutical clients are also facing increasing legislation and regulation and these obligations are passed to us in client contracts and documentation, which we in turn must pass onto our subcontractors.

**Job purpose**

With the support and direction of the Director of Compliance ensure that Adelphi Research’s internal and client-specific processes are followed so to provide compliance with all relevant country specific legislation, all professional codes of conduct/practice, rules and regulations of regulatory agencies and client specific policies and procedures.

**Responsibilities and Accountabilities**

**Adverse Event (AE) Reporting**

To take responsibility for the coordination of AE reporting ensuring client specific processes are followed.
- Ensure that relevant staff understand and adhere to AE reporting obligations according to Adelphi standards and client-specific procedures: Conduct client-specific training when appropriate and assists in setting up
- Provides orientation and ongoing training to new hires as needed
- Train subcontracted fieldwork suppliers/analysts when appropriate
- Maintain an internal database for AE reporting
- Provide induction and ongoing training as required, assisting with training queries
- Provide training on internal processes and standard operating procedures
- Ensure that all Adelphi training records are filed and logged in the client folders and that all internal systems are updated with the relevant client specific information. Ensure that appropriate records are maintained to meet client specific and regulatory requirements.
- Provide support in the AE review of data collection materials including review of the AE rule document.
- Provide support with client-specific processes including: interaction dates; reconciliation; source data verification.
- Review data for potential AEs and complete Source Data Verifications.
- Organise, liaise and manage 3rd party when requiring cover for AE reporting
- Alerts staff to AE requirements when new projects are awarded, providing tools to ensure compliance (i.e., quick reference guides, forms, and where possible, client products lists)
- Offers advice and guidance to staff when requested regarding questions in survey instruments that may solicit AEs; assists on client calls regarding AEs whenever needed.
- Liaises with clients’ drug safety departments to:

- Actively pursue answers to client-specific questions
- Help project staff to better understand client needs to ensure compliance
- Ensure tasks and activities are performed according to client specifications, procedures and policies in place
- Ensure that Adelphi is in compliance with all specific client AE documentation and regulations.

**Audits**:

- Organise and complete the necessary internal preparations for the external ISO annual audit, liaising with the Senior Mgt Team and Group Compliance
- Conduct internal audits and raise corrective actions as specified by the Compliance Director.
- Assist in the preparation of documentation to meet regulatory and specific client requirements, such as SOPs.

**Project Close-Out process**
- Manage all compliance aspects of the project close out process

**Data Privacy**
- Be conversant with global data privacy requirements and specific client privacy requirements.

**Ethical and Legal Responsibilities**

Provide advice and support on ethical and legal responsibilities, when conducting market research.
- Define processes and procedures to meet legal and regulatory and client specific requirements.
- Provide clear guidance and practical advice to researchers. Offer alternative solutions if appropriate.

**Skills a