clinical trial CoordinatorPPD

Summarized Purpose:
Provides administrative and technical support to Project Team. Coordinates responsibilities of project administration as applicable to client contracts under direction. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Responsibilities may include but are not limited to: performing file reviews at any level, preparing project meeting minutes, mass mailing and communication to sites, processing regulatory and other study-specific documents, entering quality data, reviewing and updating document metrics and findings, submitting documents to the files, updating and maintaining vendor trackers and maintaining data repositories. For positions withing Clinical Monitoring, detailed tasks and responsibilities, are outlined in the task matrix.
Essential Functions:
According to the specific role (Central or Local), coordinates, oversees and completes administrative functions on assigned trials activities detailed on the task matrix, including but not limited to the following:
Reviews and tracks local regulatory documents, handles wet-ink documents as required per study/sponsor specifications. May transmit documents to client and centralized IRB/IEC
TMF/Project file set-up (Central and Internal files). Submits documents to TMF. Analyzes and reconciles project documents, metrics and findings reports within specified timelines.
Processes local payments (translations, EC/IEC, other local vendors, etc.)
Performs mass mailings and communication as needed.
Maintains vendor trackers.
Provides accesses to company, client and vendor systems.
Assists with coordination and compilation of Investigator Site File (ISF) and Pharmacy binder materials. Distributes (ISF) and Pharmacy binders and other paper supplies to sites. Performs file review at any required level (Central, Internal, Country and/or Investigator) and records findings in CTMS as applicable.
Assists with study-specific translation materials and translation QC upon request.
Assists with clarification and resolution of findings related to site documentation.
Maintains assigned data points within CTMS according to the established conventions within specified times, including entry of findings
Assists on project management ad-hoc activities, produces reports, assists on study plans edition.
Coordinates team conference calls, completes and distributes meeting minutes from internal/client/vendor meetings as applicable
Involvement on Go-Balto use during study Start up.
Involvement on CTMS triage activities to assist on RBM strategy.
Provides ad hoc support as needed.
Qualifications
Education and Experience:
Bachelor's degree in life science/healthcare-related courses (Pharmacy, Nursing, Med Tech, Biology, etc)
Previous general administrative experience preferrably in clinical research administration that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
Knowledge, Skills and Abilities:
Ability to work in a team or independently, as required
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 prioritize workload to meet changing project timelines
Demonstrated ability to attain and maintain a good working knowledge of ICH GCP, applicable regulations and PPD/Client procedural documents for all non-clinical/clinical aspects of project implementation, execution and closeout
Good English language and grammar skills are needed while proficiency is mandatory for Centralized role
Good computer skills, proficient in MS Office, ability to obtain knowledge and master all clinical trial database systems. Leverage modern technology when applicable
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Skills to work under constant pressure to meet project/client deliverables and timelines
PPD

Taguig City, Metro Manila
Permanent
Full-time