Clinical Trial Coordinator I - FSP

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 bioteches, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

• Drafts, reviews, negotiates and finalizes amendments and budgets with study sites in accordance with local/accepted process.

• Negotiates within approved parameters both investigators grant budget negotiation parameters, contractual terms and conditions in accordance with contractual considerations, client contractual considerations, established process with clients and follows established escalation routes.
• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations.

• Ensures compliance of budgetary guidance, templates and process.

• Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• Documents in real time all communication, attempts an follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.

Education and Experience Requirements:
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 year).
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Basic ability to apply basic principles of investigator grant negotiation.

• General understanding of business and financial principles that related to service agreements.

• Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Ability to successfully complete the organizations clinical training program
• Self-motivated, positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Good interpersonal skills
• Essential judgment and decision-making skills
• Capable of accurately following project work instructions
• Good negotiation skills
• Independent thinker
• Ability to manage risk and perform risk escalation appropriately