Clinical Research Associate (CRA, Senior CRA, In-house CRA, Unblinded CRA) Old Saybrook United States,
Iterum Herapeutics (company)
This role will assist Project Managers in the design, planning, implementation and monitoring of clinical studies. Ensures studies are conducted, recorded and reported in accordance with the clinical protocol, standard operating procedures, ICH-GCP and other applicable regulatory requirements.
The main responsibilities of the CRA role may include, but are not limited to:
- Manage key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection and close-out.
- Independently conduct monitoring visits at investigational sites, including site qualification, initiation, progress and close-out visits. Prepare and submit monitoring visit reports in accordance with SOPs and procedural documents.
- Train investigational site personnel to the clinical protocol and industry standards including ICH-GCP.
- Verify study data on source documentation and case report forms to ensure compliance with the study protocol. Identify and resolve data discrepancies.
- Assist in the preparation of study documents including, but not limited to, clinical protocols and amendments, case report forms, informed consent forms, site training materials and clinical study reports.
- Obtain, collate and file essential clinical documents in accordance with SOPs and procedural documents.
- Willingness to travel up to 75% of time, unless role is for In-house CRA.
- If assigned to an unblinded team, carry out all required unblinded monitoring activities.
- Participation in initiatives and/or other activities as directed.
Training and Education :
- Bachelor’s degree or equivalent experience in relevant field (science, nursing, medical or pharmacy degree preferred).
- 2-3+ years of experience in monitoring of investigational sites and managing, training and mentoring of other CRAs.
- Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct.
- Experience of coordinating people and time management.
- Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates.
- Makes independent choices and takes responsibility for own actions.
- Recognizes potential obstacles and works to resolve them within set timelines.
- Conscientious and precise in delivery of work even when under pressure.
- Collaborative and team oriented.
- Excellent oral and written communication skills.
- Exhibits a confident and influential approach.
- Understands customer needs.
- Excellent planning, organizing, interpersonal and leadership skills.
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