AlamatDeskripsi
Job Description
Coordinates and oversees all clinical aspects on a study for assigned sites from start-up to close-out, as applicable per study specifications and as defined in PPD SOPs and Task Matrix. Performs remote site monitoring activities and reviews subject data on an ongoing basis in line with PPD and/or Client procedures . To ensures that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs and to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with client company personnel and investigational sites. Contacts study sites to discuss study status, monitoring findings and issues and requests outstanding information and documentation. Triggers on-site monitoring indicating areas of focus, in order to guarantee that pertinent tasks and identified findings are addressed. Plays an active role within the clinical team to reach clinical goals, achieve deliverables and meet project deadlines.
- Completes study and site management activities as defined in task matrix, and as applicable to study assigned
- Completes and documents study-specific training.
- Orients and trains on any PPD/study-specific systems.
- Performs assigned duties in accordance with PPD/Client SOPs and regulatory guidelines.
- Identifies potential investigators at study start in collaboration with client company, Global Investigator Services (GIS) and start-up team to ensure acceptability of sites.
- Performs and coordinates tasks related to Pre-Study Assessment (PSA), as per project specifications and as defined in the task matrix.
- Coordinates and oversees site start-up activities during pre-activation phase to identify, escalate and mitigate any risks to site activation, in close interaction with Start-up Team Manager/ Clinical Team Manager (STM/CTM), Country Approval Specialiast (CAS) and Contract Specialist (CS).
- Reviews and discusses site's recruitment strategies and enrolment targets from site identification through recruitment phase, per study guidance Triggers On-site Site Initiation Event/ On-site Monitoring Event/On-site Close-out Event in accordance to PPD, Project specific tools/guidelines and/or client procedures.
- Performs Remote Pre-study Assessment/Site Initiation Event/ Monitoring Event/ Close-out Event, as needed, in accordance to PPD, Project specific tools/guidelines and/or client procedures.
- Supports and attends Investigator's Meeting (in person or virtual), as applicable. Actively particpates in Clinical Internal Meetings
- Performs and documents on-going Data Reviewand performs regular contact with sites to discuss monitoring findings and assess protocol compliance.
- Conducts monitoring tasks remotely in accordance with the approved monitoring plan and based on the available centralized monitoring/data analytics tools. Introduces corrective/preventive actions to bring the site into compliance and decrease risks, where needed.
- Takes ownership for follow up on identified risks/issues through to successful resolution.
- Provides updates on potential trends noted across multiple sites and discusses potential remedial strategies to the (CTM).
- Ensures clinical country and site level documentation is completed and filed in a timely manner in-house Country and Investigator Files.
- Contributes to the project team by mentoring new members and CRAs, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share potential solutions for improvements.
- Oversees and coordinates tasks related to study and site amendments in collaboration with study team, as defined in Task Matrix.
- Ovesees and coordinates tasks on site payments, as defined in the Task Matrix.
- Performs additional tasks as assigned by CTM or Manager, Clinical Operations.(e.g. trip report review, newsletter creation, lead CRA team calls etc).
- Provides trial status tracking and progress update reports to the (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- May perform On-site monitoring under some circumstances (e.g. CRA vacation coverage, short term leave, Co-Monitoring to clear backlog/study timeline).
- May assist on performance assessment/ management of the CRAs.
- Responds to company, client and applicable regulatory requirements/audits/inspections federal regulatory requirements/audits.
- May perform a specific role profile for FSP opportunities according to Client requests.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
