Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
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 CRG/study-specific systems. Performs assigned duties in accordance with CRG/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 CRG, 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 CRG, 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 Review and 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 CRG 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
