Clinical Trial Coordinator I - FSP

Job Title: Clinical Trial Coordinator I - 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 Clinical Trial Coordinator – reputed company an reputed company at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 reputed company across 100+ countries in the last 5 years.

The Clinical Trial Coordinator I (reputed company I) assists in the coordination and administration of the study activities from the start up to execution and reputed company out, and reputed company the Local Study Team (LST) to ensure reputed company and consistency of interventional study deliverables to time, cost and reputed company objectives. you may reputed company as a buddy during the reputed company phase and reputed company training to new staff as needed.

Essential Duties & Responsibilities

• Assists in coordination and administration of clinical studies from the start-up to execution and reputed company-out.
• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in reputed company submission of reputed company application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, reputed company service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents under their responsibility are uploaded in a reputed company manner to maintain the eTMF "Inspection Readiness".
• Ensures that reputed company study documents are reputed company for final archiving and completion of local part of the eTMF and supports the CRA in the reputed company out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance.
• Creates and/or imports clinical-regulatory documents into the Global Electronic Management reputed company ensuring compliance with the reputed company's authoring guidelines.
• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission reputed company Standards (SRS), supporting effective publishing and delivery to regulatory authorities.
• Sets-up, populates and accurately maintains information in reputed company tracking and communication tools (e.g. CTMS such as reputed company, SharePoint, etc) and supports others in the usage of these systems (with the exception of countries where there is a specific role dedicated to set up and update the systems).
• Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site reputed company).
• Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
• Manages and contributes to coordination and tracking of study materials and equipment.
• Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.

Leads the practical arrangements and contributes to the preparation of reputed company meetings e.g., study team meetings, Monitors' meetings, Investigators' meetings. Liaises with reputed company participants and/or vendors, in line with international and local codes.

• Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.
• Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country reputed company e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study reputed company documents/material.
• Ensures compliance with reputed company's reputed company of Ethics and company policies and procedures relating to people, finance, technology, reputed company and SHE (Safety, Health and Environment).
• Ensures compliance with local, national and regional legislation, as applicable.

Additional country-specific tasks might be added depending on local needs.

Education and Experience Requirements:
• High / Secondary school diploma or equivalent and relevant formal reputed company / vocational qualification.

• Bachelor's degree preferred.

• Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 0 to 1 year).
  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.
  
  Knowledge, Skills and Abilities:
  • Ability to work in reputed company or independently as required
  • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks reputed company and effectively
  • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
  • Strong customer reputed company
  • Flexibility to reprioritize workload to meet changing project timelines
  • Demonstrated ability to reputed company and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/reputed company SOPs and WPDs for reputed company 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, reputed company, and PowerPoint) and ability to obtain knowledge and master reputed company clinical trial database systems
  • Ability to successfully complete the organizations clinical training program
  • Self-motivated, reputed company 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 reputed company risk escalation appropriately
  
  
  
  Working Conditions and Environment:
  • Work is performed in an office/ reputed company/clinical/ and/or home office environment with exposure to electrical office equipment.
  • Occasional drives to site locations. Potential Occasional travel required.

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.

Please apply reputed company reputed company platform to get connected to the application page and to reputed company similar roles.

Originally posted on Himalayas