Clinical Trial Assistant

1 month ago

Mumbai, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with guidance/support. Assist in the preparation of study and site-specific materials in accordance with relevant SOPs. Complete minute taking and documentation for sponsor/external or internal teleconferences as requested. Assist in setting up and maintaining tracking systems/spreadsheets for e.g., study supplies. Maintain the Project Directory. Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting. Provide support to project team (e.g., proof-reading and editing correspondence, mailings, shipping of study files, faxing and photocopying documents, assembling study documents, and arranging meetings, etc.) Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable. Audit and CAPA tracking. Set up and maintain clinical investigator files and documentation. Liaise with vendors, as needed, for study conduct such as printing study materials and/or external systems access for study team members. Coordinate and plan study supply shipments with vendors. Maintain and confirm shipment information such as courier tracking numbers and date of shipping and delivery. Prepare/assemble/ship supplies to sites pre-SIV: Study File Notebooks, CRFs, other study-specific ancillary supplies (i.e., diary cards, patient visit reminders). Generate reports as needed, for example CTMS site contact information list. Work with the In-House CRA and other project team members on reconciliation of data with CTMS. General communications to sponsors, sites and internal team members via electronic mail or courier or telephone. Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead. All other duties as needed or assigned.

Qualifications (Minimum Required):

Diploma – Associate degree or equivalent. In lieu of the above requirement, candidates with 1-2 or more years of relevant Clinical Research experience in pharmaceutical or CRO industries may be considered.

Experience (Minimum Required):

Minimum one (I) year administrative experience or equivalent training. Good oral and written communication skills. Good organizational and time management skills.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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