FSP Clinical Trial Coordinator II
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Job Description
Clinical trial coordinator supporting site activation, regulatory documentation, and feasibility for global pharmaceutical and biotech research. Managing trial records, site communications, metrics, and study-startup activities.
Responsibilities:
- Coordinate, oversee, and complete assigned trial activities according to the task matrix
- Perform department, internal, country, and investigator file reviews and document findings
- Complete allocated tasks on time, within budget, and to a high-quality standard; communicate risks to project leads and line manager
- Process client (e)TMF documents, perform (e)TMF reviews, distribute mailings and communications, and provide documents and reports
- Review and track local regulatory documents
- Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings
- Maintain vendor trackers and study status information in databases
- Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Support study-specific translation materials and translation quality control
- Provide technical and administrative project support in collaboration with internal departments and team members
- Maintain knowledge of SOPs, client directives, and current regulatory guidelines
- Maintain client local-affiliate relationships where applicable
- Train new personnel and support departmental process improvements
- Maintain study documentation, team lists, training requirements, system access, activity plans, and (e)TMF records
- Provide system support for Activate and eTMF and may support RBM activities
- Transmit documents to clients and centralized IRB/IEC
- Attend kick-off meetings, take notes, and support meeting scheduling and minutes
- Coordinate with internal departments to align site start-up activities with the site activation critical path
- Prepare regulatory compliance review packages and support regulatory submissions
- Obtain site-selection documents and develop site lists from internal and external sources
- Maintain investigator/site staff contact details and complete Site Interest Plans in CTMS
- Review survey data and ensure effective site contact and follow-up plans
- Collaborate with teammates and clinical personnel on site issues, risks, deadlines, and escalations
- Act as a local expert on site capacity and experience; support site tiering and recommend additional sites
- Conduct phone interviews with physicians and site personnel regarding standard of care and protocol input
- Liaise with Global Investigator Services and contribute to global feasibility processes and best practices
Requirements:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Bachelor's degree preferred
- At least 2 years of previous experience providing relevant knowledge, skills, and abilities
- Equivalency may be considered through a combination of appropriate education, training and/or directly related experience
- Ability to work independently or in a team environment
- Strong organizational skills and attention to detail; ability to manage multiple tasks efficiently
- Ability to analyze project-specific data/systems for accuracy and efficiency
- Strong customer focus, flexibility, adaptability, and reprioritization skills
- Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
- Excellent English language and grammar skills and proficient local language skills as needed
- Good presentation, negotiation, interpersonal, oral and written communication skills
- Proficiency in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems and appropriate software
- Ability to complete the organization's clinical training program
- Basic medical/therapeutic area and medical terminology knowledge
- Basic organizational, planning, and local health systems knowledge
- Ability to attain and maintain knowledge of GCP and applicable SOPs
- Ability to work in a matrix environment, manage risk, and perform risk escalation appropriately
- Fluency in the local language and good command of English
- Potential occasional travel and occasional drives to site locations
Benefits:
- Fully Remote work arrangement
- Full-time employment
- Standard Monday–Friday work schedule
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