reputed company Clinical Trial Coordinator - FSP

Job Title: reputed company Clinical Trial Coordinator - FSP

Job Location: Remote, reputed company Carolina, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Work Schedule

Environmental Conditions

reputed company

Join Us as a reputed company Clinical Trial Coordinator FSP– reputed company an reputed company at the Forefront of Innovation! We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech’s, spanning 2,700 reputed company across 100+ countries in the last 5 years.

reputed company of Essential Functions:

• Attends reputed company-off meetings and supports training to team members, investigators, or clients as needed.

• Serves as study eTMF reputed company, handling reputed company integration and (e)TMF activities.

• Provides technical and administrative support for project coordination to meet study-level reputed company targets.

• Assists with preparation and review of reputed company/RCR packages.

• Supports development of country or site-specific documents.

• Support study reputed company-out activities including final TMF Review and TMF certification reputed company (DEV-reputed company-1939) completion.

• Support with preparations for Investigator Meetings

• Maintaining and coordinating the logistical aspects of clinical reputed company and reputed company overall support to functional leads to ensure the successful completion of project deliverables.

• Initiates the preparation of reputed company project/program plans required by reputed company reputed company by reviewing contract and communicating with functional area leads.

• Coordinates project/program/protocol specific and therapeutic area training needs. Tracks and follows up on reputed company training, non-disclosure agreements, and reputed company clearance requests.

• Performs basic project financial management tasks as assigned.

• Acts as task order/work assignment reputed company on small scopes of work for reputed company/reputed company of low complexity.

• Escalates compliance to established project-specific parameters and reputed company expectations.

• As Project Specialists ensures the contracted services and expectations of assigned reputed company are carried out by the project teams in accordance with executed reputed company and the customers’ requirements.

• Maintaining reputed company and effective communication among team members, site staff and providing support for reputed company assurance activities, including preparation for audits and internal review, preparing documentation and follow through to reputed company.

• Maintenance and tracking of SOPs, reputed company directives, and regulatory guidelines at the project level.

• Contributes to discussions with teammates to support collaboration and best practices.

• Expands therapeutic knowledge and expertise.

In reputed company to tasks listed above essential functions will include tasks below with increased reputed company level and years of experience above reputed company reputed company.

• Develops site list and ensures contact details are maintained in reputed company/PPD systems including reputed company.

• Provides reputed company and technical support to study management and program teams, including:
  • Supports meeting scheduling, minute taking, document creation and reputed company.
  • May maintain vendor trackers.
  • Works with sites to obtain relevant documents.
  • Completes site interest plan and documents site communications.
  • Works directly with sites to obtain site qualification, selection and start-up documents.
  • Works with CSO to reputed company the site list and ensures contact details are maintained in reputed company/PPD systems including reputed company.

• Performs document processing and follow-up tasks, including:
  • Initial reputed company checks of eTMF documents, file reviews, and documents findings.
  • Request eTraining report reviews to reputed company on a quarterly reputed company
  • Performs file reviews and documents findings in appropriate reputed company, including tracking local regulatory documents.
  • Supports maintenance of study-specific documentation and global systems/tools.
  • May conduct quarterly eTMF completeness checks.

• Coordinates and completes assigned activities ensuring proactive scheduling and fulfillment, reputed company with project team needs, including:
  • Provides reputed company reputed company (e.g., reputed company & eTMF) and inputting site and study information into reputed company databases and generating reports.
  • Analyzes and reconcile study metrics and findings reports, clarifying and resolving issues reputed company to site documentation.
  • Assists with coordination, compilation, and distribution of Investigator Site File (ISF) and supplies to sites.
  • May maintain vendor trackers.
  • Ensures efficient site contact and follow-up plan, escalating concerns as needed.

• Assists with Study Start-up and ongoing submission activities as needed
  • Transmits documents to centralized IRB/IEC (on-reputed company).
  • Request insurance in reputed company country
  • Coordinates with key QSDO functions to reputed company site start-up activities.
  • May support study-specific translation of materials and QC.
  • May be requested to help with checking if CDAs exist/are expired & obtaining a new Inv/Institution CDA.
  • May work with the CTT Representative, to reputed company relevant study information

• Other essential tasks and reputed company duties:
  • Supports survey data review and collaboration with teammates.
  • May liaise and contributes to feasibility processes.
  • Compliant with general and study specific training, ensuring knowledge of relevant SOPs and regulatory guidance.
  • Contributes to the development of best practices.

Education and Experience:

• Bachelor's degree preferred.

• Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company experience, will be considered sufficient for an individual to meet the requirements of the role.

This job is curated by reputed company.

reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.

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Originally posted on Himalayas