Senior Clinical Research Associate - Remote Contract

Evolution Research Group; United States; Remote; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Lotus Clinical Research is seeking a Contract Senior Clinical Research Associate to monitor clinical sites for multiple trials from a remote US base. The role requires travel and independent site management in compliance with SOPs, FDA regulations, ICH, and GCP.

You will lead initiation, monitoring, and close-out activities, ensure audit-ready Trial Master Files, and serve as the primary site contact, coordinating data transmission and study documentation with investigators.

Qualifikationen

• Bachelor's degree or equivalent in life science/healthcare.
• Minimum 5 years of field experience working within clinical research as a CRA.
• Valid Driver’s License.
• Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency.

Aufgaben

• Independently manages and monitors site activities for assigned clinical studies, working individually or co-monitoring with other CRAs.
• Monitoring activities will include but not be limited to site qualification, site initiation, interim monitoring, and close-out visits.
• During monitoring visits, the CRA ensures compliance with the protocol and applicable SOPs, FDA regulations, and ICH-GCP guidelines.
• Independently and proficiently performs site evaluation visits of potential investigators.
• Expertly and independently performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the case report forms, monitoring activities and study close-out activities.
• Ensures the Investigator Site File is kept audit-ready and ensures documents are collected and uploaded into the Trial Master File on a regular and timely basis.
• Has direct communication with investigational sites on visit planning, query resolution, action item resolution, and any other activities to support site management.
• Independently documents accountability, stability and storage conditions of clinical trial materials as required by the Monitoring Plan.
• Serves as primary contact with the site; coordinates all correspondence; ensures timely transmission of clinical data with the study site.
• Expertly and independently performs study close-out visits per the study specific Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• Ensures internal and study-related trainings are completed per Lotus and/or study timelines.
• Pre and post visit follow up include compliance to timelines indicated in the Monitoring Plan for Confirmation Letters, Follow up Letters and Monitoring Visit Reports.
• Performs other related duties as requested.

Kenntnisse

Drug development

ICH/GCP

Electronic CRF

Interpersonal skills

Attention to detail

Organizational skills

Independent work

Ausbildung

Bachelor's degree in life science/healthcare

CRA II responsibilities

Jobbeschreibung

Lotus Clinical Research is seeking a Contract Senior Clinical Research Associate to monitor clinical sites for multiple trials from a remote US base. The role requires travel and independent site management in compliance with SOPs, FDA regulations, ICH, and GCP.

You will lead initiation, monitoring, and close-out activities, ensure audit-ready Trial Master Files, and serve as the primary site contact, coordinating data transmission and study documentation with investigators.