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Job Opportunity: Clinical Trial Coordinator (CTC)

 
Date   Jul 10
 
Listing No.   IE267154
 
Sector   Pharmaceutical
 
Region   Center
 
City/Yishuv   Hod Hasharon
 
 
Clinical Trial Coordinator (CTC)
 
We are looking for a Clinical Trial Coordinator who will coordinate trial and site administration, document management, budgeting and payments, as well as meeting planning.

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Responsibilities

Track (e.g. essential documents) and report (e.g. Safety Reports)
Ensure collation and distribution of study tools and documents
Update clinical trial databases (CTMS) and trackers
Prepare documents and correspondence
Collate, distribute/ship, and archive clinical documents, e.g. eTMF
Assist with eTMF reconciliation
Execute eTMF Quality Control Plan
Update manuals/documents (e.g., patient diaries, instructions)
Document proper destruction of clinical supplies
Prepare Investigator trial file binders
In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
Obtain, track and update study insurance certificates
Support preparation of submission package for IRB/ERC and support regulatory agencies submissions
Publish study results for GCTO and RA where required per local legislation
Develop, control, update and close-out country and site budgets (including Split site budget)
Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
Track and report contract negotiations
Update and maintain contract templates (in cooperation with Legal Department)
Calculate and execute payments (to investigators, vendors, grants)
Ensure adherence to financial and compliance procedures
Monitor and track adherence and disclosures
Maintain tracking tools
Oversight on out-tasking activities
Maintain fluent communication between the company and Vendors
Organize training activities with the vendor and SMEs
Collect feedback for process improvement
SME for out-tasking activities and processes
Define & agree on metrics to assure quality and service expectations
Perform frequent meetings to align the teams & processes
Support and Lead new processes for implementation
Organize meetings (create & track study memos/letters/protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Qualifications

Minimum 1 in Clinical Research or relevant healthcare experience
Junior CTC with up to one year of experience
Completed job training (office management, administration, finance, health care preferred) or B.A./B.S. (Life Science preferred) or equivalent healthcare experience
Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines
Hands on knowledge of Good Documentation Practices
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required
ICH-GCP Knowledge appropriate to role
Excellent negotiation skills for CTCs in finance area
Effective time management, organizational and interpersonal skills, conflict management
Effective communication with external customers (e.g. sites and investigators)
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment
 
 
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