JOB DESCRIPTION

Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and SOPs.

Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Responsible for ensuring that data will pass international quality assurance audits. Represents the company in medical research community and develops and maintains 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 compliant process on time and within budget.

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.

8.          As necessary, prepare and submit regulatory, ethics committee and provincial applications and regulatory packages

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.      Organize and participate in investigator meetings as necessary

12.      Provide trial status tracking and progress reports as required by the Project 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 and clinical operations lead in writing

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

18.      Facilitate effective communication between investigational sites and the MyXMO 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:

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

Skills and knowledge:

– Knowledge and understanding of relevant regulations, e.g., ICH/GCP, FDA guidelines

– 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

– Basic medical/therapeutic area knowledge and medical terminology preferred

– Ability to work in a team or independently as required

– Ability to travel and spend 30 – 50% of working week at site