Oversee Clinical Research Associate (CRA) and all associated monitoring activities. Provide leadership and oversight to Clinical Research Organizations (CROs) ensuring compliance to responsibilities as outlined in the transfer of obligations and in accordance with CRO and sponsor policies, procedures, SOPs, ICH/GCP guidelines.
Compass Consulting Experience:
- Bachelor’s degree in nursing.
- 7+ years of clinical trial monitoring and management with industry leading Biotech and emerging start-up companies.
- Proven leadership in CRO bid defense discussions and ability to provide insight and content into contracts and scope of work.
- Participate in issue escalation and governance committees for CROs and vendors.
- Ability to partner with senior leadership, and other applicable departments, in the development, review and implementation of departmental SOPs and business improvement innovation initiatives.
- Managed operation of clinical research sites, site selection, initiation, regulatory, patient enrollment, site maintenance, patient follow up, and study close out for PMA and 510(k) dialysis access trials.
- Proctored and trained investigators and staff during surgical implant for study enrollments and interventional follow up events.
- Coordinated site enrollment strategies and spearheaded referral outreach programs.
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