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.
1) Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems with minimal guidance and support 2) Assist in the preparation of study and site specific materials in accordance with relevant SOPs
3) Complete minute taking and documentation for sponsor/external or internal teleconferences as requested
4) Create and maintain tracking systems/spreadsheets for e.g. study supplies 5) Maintain the Project Directory
6) Provide support for Investigator Meetings; track meeting attendees and/or other information regarding the Investigator Meeting
7) Provide support to project team (e.g., proof-reading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.) 8) Maintain Trial Master File documentation within the appropriate TMF platform, participate in TMF QC, as assigned, and track and /archive as applicable 9) Audit and CAPA tracking
10) Set up and maintain clinical investigator files and documentation
11) 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);
12) Generate reports as needed, for example the CTMS site contact information list.
13) Work with the In-House CRAs and other project team members on reconciliation of data with the CTMS.
14) General communications to sponsors, sites and internal team members via electronic mail or courier or telephone
15) Perform other administrative duties as assigned by Line Manager, Project Managers or Clinical Trial Lead.
16) Train and mentor less experienced Clinical Trial Administrators
17) May serve as the Lead CTA on projects where there is more than 1 CTA (provide guidance, facilitate teleconferences, task review, task delegation)
18) Liaise with other departments to ensure project delivery
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. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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