Senior Clinical Research Associate myoscience
THIS JOB HAS EXPIRED The Clinical Research Associate monitors activities of a clinical study and at clinical study site to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols.
Review regulatory documents as required and prepare site visit reports.
Responsible for multiple projects and must work both independently and in a team environment.
Participates in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific PI/CRC/CRA training.
May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed.
Additional duties will include, but are not limited to:
1.Conducts clinical monitoring of field sites to supervise and coordinate clinical studies.
2.Ensuring implementation in accordance with appropriate SOPs, ICH/GCP guidelines and federal, state and/or local regulations.
3.Contribute to study concept documents, protocols, clinical study reports, etc.
4.Serve as the primary study contact during trial conduct including regular phone conferences and meetings with appropriate functional areas and vendors as necessary.
5.Provide management with routine updates regarding the status of program.
6.Manage clinical trial and/or sites from start-up through maintenance to close out.
7.Assist Vendor Management - selection, negotiation, implementation and management of vendor Statements of Work (SOW).
8.Assist in management of study budget, timelines, and insourcing/outsourcing partners.
9.Assist in the planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution or escalation of issues, and communication of study timelines/deliverable.
10.Collect, track and report established KPIs such as query resolution, AE/SAE data collection, drug reconciliation/shipment, site and patient enrollment, etc.
11.Ensuring adequate protocol related and process training of all study team members.
12.Management of protocol deviation/violation documentation.
13.Tracking steps and preparation for interim and primary analysis reports.
14.Assist in preparation and oversight/coordination of Investigator Meetings.
THIS JOB HAS EXPIRED