Location: Remote/Work From Home (must be based out of Seattle, WA area)
The Senior Regional Site Manager (Senior RSM) is responsible for overseeing the conduct of clinical trials at investigative sites to ensure the quality and integrity of data and to ensure that the rights and welfare of research subjects are protected.
The Senior RSM conducts all monitoring visits in accordance with company standards. The Senior RSM exercises responsibility across multiple projects and therapeutic areas. The Senior RSM interfaces with clinical investigators, other site staff and company personnel in order to carry out this responsibility.
The Senior RSM is completely accountable for site management and data quality for each assigned site. In addition, the Senior RSM may hold other assignments, such as Lead Site Manager, Global Site Management Operations Subject Matter Expert (SME), Contract Research Organization (CRO) Oversight Representative, or any other project assigned by Global Site Management Operations management.
1. Conduct the following monitoring visits according to applicable SOPs, Working Documents, GCP/ICH guidelines, Protocol Specific Monitoring Plans, and departmental timelines as follows: • Site Qualification Visits (SQVs) • Site Initiation Visits (SIVs) • Interim Monitoring Visits (IMVs) • Remote Monitoring Visits (RMVs) • Close-out Visits (COVs)
2. Manage all site activities for assigned sites including: • Partnering with sites to ensure recruitment goals are met. • Assisting sites with operational needs (e.g. vendor activities, site payment). • Primary contact for all issues that arise with sites.
3. Communicate site status and monitoring activities, as follows: • Submit monitoring visit reports (MVRs) for all monitoring visits conducted. • Send follow-up letter to Principal Investigator summarizing visit conduct and all action items. • Contact the Regional Operations Manager (ROM) and Project Lead (PL) regarding significant site conduct issues. • Complete GXP Compliance audit responses in conjunction with ROM and PL.
4. Meet all departmental timelines and deliverables for the following activities: • Submission of MVRs in CTMS. • Submission of MVRs to the TMF. • Freezing of all electronic case report forms. • Retrieval of all paper case report forms (if applicable). • Maintenance of calendar. • Submission of weekly time and expense reports.
5. Attend and participate in all relevant meetings, as follows: • Annual Global Site Management Operations meeting • Regional Global Site Management Operations meetings, as scheduled. • Investigator Meetings for all assigned studies. • Regional Site Manager teleconferences for all assigned studies. • Regular regional teleconferences.
Allied Health Professions degree (PA, RN, RPh), relevant clinical experience or four-year life science degree.