(Senior) Clinical Research Associate

7 days ago

Singapore AFFINITY HUMAN VENTURE LLP Full time

**Basic Purpose and objective**:Performs and coordinates all aspects of the clinical monitoring process in accordance with ICH GCP and FDA guidelines and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. Responsible for ensuring that data will pass international quality assurance audits. Represents PPD Development in the global medical research community and develops collaborative relationships with investigational sites.

**Position scope**:Serves as a primary contact with individual investigational sites that conduct clinical trials. Successful site management contributes directly to operational objectives, which in turn have an impact on project profitability. Goal is to deliver clean CRFs from an ICH GCP and SOP/WPD compliant process on time and within budget.

**Supervisory responsibilities**:This position has no direct supervisory responsibilities

**Duties and Responsibilities (according to relevant guidelines, laws and SOPs)**

1. Identify potential investigators in collaboration with the sponsor.

2. Perform evaluation visits to assess facilities and staff so as to ensure the selection of appropriately qualified investigative sites

3. Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted

4. Perform monitoring duties as specified in the relevant procedures

5. Verify data versus source documentation and validate CRF entries

6. Generate and resolve queries as required

7. Control investigational product accountability through physical inventory and records review. Control trial supplies ordering, dispatch, return and destruction, where applicable.

9. Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study - prepare Regulatory Compliance Review packages

10. Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc

11. Organise and participate in investigator meetings as necessary

12. Provide trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager

13. Administer investigator payments

14. Conduct and ensure proper trial close out and retrieval of trial materials

15. Archive relevant documents as per procedures

16. Clearly document all observations in reports and letters in a timely manner, according to accepted business writing standards. Ensure that any serious issues are immediately raised to the attention of project management, clinical team management and clinical operations management in writing

17. Maintain a working knowledge of GCP, Corporate global SOPs and applicable client SOPs

18. Facilitate effective communication between investigational sites and the PPD project team through written, oral and electronic contacts

19. Facilitate and respond to company, client and regulatory audits

20. Contribute to the project team by mentoring new members, assisting in preparation of project tools and sharing ideas and suggestions with team members.

**Qualifications**:Bachelor’s or higher graduate degree in a science related field, licensed or certified health care training or equivalent experience

Valid driving license (where applicable)

Valid passport

**Skills and knowledge**:Effective oral and written communication skills

Excellent interpersonal skills

Strong attention to detail

Basic computer skills and the ability to learn appropriate software

Good English language and grammar skills + second language mandatory (French or Dutch, preferably both)

Basic medical/therapeutic area knowledge and medical terminology preferred

Ability to work in a team or independently as required

Ability to travel and spend 60% of working week at site.

**Experience**:A minimum of 3 years experience as a Clinical Research Associate

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