Study Initiation Coordinator

Our client, a well established pharmaceutical organization, is currently in need of a qualified,

 

STUDY INITIATION COORDINATOR

 

SUMMARY:
Assists the Study Initiation Services team to ensure that all study start-up activities and deliverables to the sponsor are met on time, in accordance with client expectations, OCR standards and SOPs, and FDA/ICH guidelines and regulations.

RESPONSIBILITIES:
?Assist with preparation and distribution of correspondence and documents for investigator recruitment, clinical study agreements and budgets, essential documents and investigator meetings with minimal guidance from investigator services staff
?Maintain accurate tracking record of work completed and documents returned from investigators and Sponsors and provide status reports to study initiation team as directed by the SIM per study
?Assist with contacting investigator sites to check status of outstanding documents
?Maintain familiarity with study progress by participating in study initiation team meetings, as requested; maintain familiarity with relevant FDA/ICH guidelines and regulations
?Send documents to the project master files and to the Sponsor as requested by the Study Initiation staff
?Assist in identifying and implementing best practices and continuous improvement plans within study initiation services in order to expedite study start up process
?Provide project specific and departmental administrative assistance within Investigator Services as assigned

 

REQUIREMENTS:
?Associate or 4 year degree in related science or business, or equivalent experience preferred; High school diploma required
?At least 2 years experience in a service oriented setting
?0 to 2 years experience in the Pharmaceutical Industry, CRO or clinical setting preferred
?Strong organizational, interpersonal, and communication skills, with a high degree of accuracy and attention to detail
?Ability to multi-task with strong time management skills
?Ability to prioritize and meet aggressive deadlines

**Client offers competitive benefits package.**

 

This is a contract to permanent opportunity.