Clinical Trial Coordinator - (FSP )

Lifelancer is hiring a Clinical Trial Coordinator to work remotely in the United States on a full-time basis. The role sits within a Functional Service Provider (FSP) model, providing administrative and technical support to a Project Team. It suits someone with at least two years of global clinical trial support experience who is comfortable working under the general supervision of an FSP Manager and alongside Client Management.

The company says it has supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last five years.

What you will do

• Support day-to-day clinical study activities, including regulatory inspection readiness, under the general supervision of the FSP Manager and in collaboration with Client Management.
• Work with the Clinical Operations/Study Manager, study teams, and Clinical Research Organizations (CROs) as defined by the clinical trial operating model.
• Review study documentation, including essential document packets, study plans, and informed consent forms.
• Support and oversee risk-based monitoring.
• Attend key team meetings as required, including taking minutes for selected studies.
• Support regulatory inspection readiness, such as SOP lists and storyboard collation.
• Support clinical trial systems, including CTMS and TMF activities for selected studies.
• Support vendor contract administration as required.
• Support study close-out activities, such as financial reconciliation.
• Take on additional ad-hoc activities as agreed with managers.

The posting also notes you may support audit readiness by ensuring files are reviewed according to the schedule in the organization's SOP and department guidance document. You may provide administrative support for site activation and help develop the critical path for site activation within assigned projects. Representing CRG personnel, you may use local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists for feasibility activities and to provide local input into the site tiering process. You may also act as a buddy during onboarding and train new staff as needed.

What they are looking for

• Bachelor's degree preferred.
• 2+ years' experience in global clinical trial support as a CTC or Project Coordinator.
• Experience in Phase 2 and 3 studies and global or international studies is advantageous.
• Experience across multiple therapeutic areas, including oncology, is advantageous.
• Experience with Veeva Vault and hands-on experience in the eTMF life cycle.
• Ability to work in a team or independently.
• Good organizational skills and strong attention to detail, with a proven ability to handle multiple tasks efficiently.
• Demonstrated ability to analyze project-specific data and systems for accuracy and efficiency.
• Strong customer focus.
• Flexibility to reprioritize workload as project timelines change.
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization and client SOPs and WPDs for non-clinical and clinical aspects of project implementation, execution, and closeout.
• Good English language and grammar skills, plus proficient local language skills as needed.
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint), and able to master clinical trial database systems.
• Ability to complete the organization's clinical training program.
• Self-motivated, positive attitude, and good interpersonal skills.
• Effective oral and written communication skills.
• Judgment and decision-making skills.
• Ability to follow project work instructions accurately.
• Good negotiation skills.
• Independent thinker.
• Ability to manage risk and escalate it appropriately.

Working conditions

Work is performed in an office, laboratory, clinical, or home office environment with exposure to electrical office equipment. Occasional drives to site locations and potential occasional travel are required. The work schedule is standard, Monday to Friday, and the environmental conditions are listed as office.

About Lifelancer

Lifelancer is a talent-hiring platform in life sciences, pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. This job is curated by Lifelancer, and the posting notes it was originally posted on Himalayas.