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Tigermed · 1 day ago

Senior Clinical Research Associate (Western Based CRA)

United States

Full-time

Remote

Mid, Senior Level

1+ years exp

Tigermed is a clinical research organization seeking a Senior Clinical Research Associate to manage and oversee clinical studies. The role involves project management, ensuring data quality, site selection, and training site staff in compliance with regulations.

BiotechnologyClinical TrialsHealth CarePharmaceutical

Responsibilities

Planning of project activities and study timelines based on project goal and sponsor's expectation

Organize and Lead meeting/teleconferences for study activities implementation (e.g. investigator meeting, project review meeting etc), monitoring the progress of each CRA responsible sites, and assessing overall status of the project

Develop the project management plan, monitoring plan etc as required for the study

Develop study specific tools/forms, study templates as required for the study

Develop and manage project budget

Order and ensure all clinical supplies (including drug and non-drug) are adequate for all sites throughout the study period

Ensure all team members have timely access to appropriate systems and tools, if applicable (e.g. IVRS, eCRF etc)

Organize and conduct site feasibility visits according to guidelines and make recommendation for final approval

Track study progress and ensure project is conducted according to the plan

Communicate to monitors new study information, study timelines and goals, study requirements. Responsible for raising overall project specific issues to management (e.g. Project Director, Senior Management)

Submit the weekly project report to management (e.g. Project Director, Senior Management)

Study site selection, initiation (SIV) and clinical monitoring

Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience

Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations

Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol, and requirements

Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files

Finalize budget and obtain signed contract from site, prior to site initiation visit

Provide guidance and training to entry-level CRA/CRA I/CRA II in collaboration with Line Manager

Qualification

Clinical PracticeClinical trial operationsProject managementBachelor's degreeEnglish proficiencyMicrosoft OfficeInformation-gathering skillsMedical practice knowledgeCommunication skills