FSP Sr. Clinical Trial Coordinator

Thermo Fisher Scientific • South San Francisco, CA

3d • $23 - $32

About The Position

Join Us as a Senior 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. As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Senior Clinical Trial Coordinator, you'll coordinate and facilitate project activities and may serve as a study lead, acting as a cross-functional liaison for the project team. You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements.

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 at least 4 years). 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.
• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support 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
• Excellent English language and grammar skills and proficient local language skills as needed
• Good presentation skills
• Excellent 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 PPD clinical training program
• Self-motivated, positive attitude with effective strong interpersonal skills

Responsibilities

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
• Provides system support (i.e. GoBalto & eTMF).
• Supports RBM activities.
• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Reviews and tracks local regulatory documents.
• Transmits documents to client and centralized IRB/IEC.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• May attend Kick off meeting and take notes when required.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level