Job expirat
Main Responsibilities
-Perform clinical trial initiation, monitoring and closeout activities.
-Assists with study start-up activities, site selection, and pre-study activities to identify and evaluate potential investigators.
-Assists in site evaluation and reports to Lead CRA / Project Leader as appropriate.
-Assists in submission of documents to the Ethics Committees, when required.
-Collects, reviews and tracks regulatory documents when required.
-Participates in study specific training.
-Assists with the preparation and coordination of investigator meetings and attends meeting.
-Completes pre-study visits with study site staff.
-Provide status updates of pre-study and initiation activities to Lead CRA / Project Leader.
-Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, and reviewing drug storage and accountability procedures.
-Assists in development of patient enrollment strategies with the project team and study site coordinator
-Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.
-Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with the project plan.
-Manages study site activities and provides ongoing updates of site status to Lead CRA / Project Leader.
-Completes in-house monitoring activities as appropriate, such as updating in-house site files, and completing visit reports.
-Maintains tracking records for assigned sites such as tracking of status and source document review per patient.
-Completes study site closeout visits.
-Assists with Project specific administrative activities as a member of the project team.
-Ensures site registration in Investigator Database.
-Increases knowledge of drug development process, therapeutic areas, Good Clinical Practices, and any applicable local regulatory requirements.
MD
Excellent verbal and written communication skills along with excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language.
Hays Pharma is a leading global pharmaceutical and biotech staffing business that provides mid to upper level staff involved in drug discovery, clinical development, post-approval services and commercial activities.