Clinical Trial Coordinator I - FSP

Job Title: Clinical Trial Coordinator I - FSP

Job Location: Remote, North Carolina, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Work Schedule

Standard (Mon-Fri)Environmental Conditions

OfficeJob 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 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

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

Essential Duties & Responsibilities

• Assists in coordination and administration of clinical studies from the start-up to execution and close-out.

• Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.

• Interfaces with Investigators, external 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 timely manner to maintain the eTMF "Inspection Readiness".

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close 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 System ensuring compliance with the client's authoring guidelines.

• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.

• Sets-up, populates and accurately maintains information in AstraZeneca tracking and communication tools (e.g. CTMS such as VCV, 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 contracts).

• 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 internal and external meetings e.g., study team meetings, Monitors' meetings, Investigators' meetings. Liaises with internal and external 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 related e-mails.

• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.

• Ensures compliance with client's Code of Ethics and company policies and procedures relating to people, finance, technology, security 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 academic / vocational qualification.

• Bachelor's degree preferred.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 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.

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 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

Working Conditions and Environment:

• Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.

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Originally posted on Himalayas