• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. • Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members. • Contributes to other project work and initiatives for process improvement, as required.

• Perform and coordinate all aspects of the clinical monitoring and site management process • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation • Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.) • Ensure the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability • Ensure audit readiness and develop collaborative relationships with investigational sites • Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities • Assess investigational product through physical inventory and records review • Documents observations in reports and letters in a timely manner using approved business writing standards • Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution • Maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner • Conducts monitoring tasks in accordance with the approved monitoring plan • Participates in the investigator payment process • Ensures a shared responsibility with other project team members on issues/findings resolution • Investigates and follows-up on findings as applicable • Participates in investigator meetings as necessary • Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted • Performs trial close out and retrieval of trial materials • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations • Conducts on-site file reviews as per project specifications • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required • Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System) • Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts • Responds to company, client and applicable regulatory requirements/audits/inspections • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner • Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members • Contributes to other project work and initiatives for process improvement, as required

Exclusive AI in Tech Study Series – Earn starting from $100 + Bonuses! Pulse Labs is a research company that helps companies that are building leading technologies. We’re currently seeking participants for an exciting AI in tech series of study! Study Duration: ~1.5-2 hours over one week per study (starting soon!) Eligibility: -Work in technology as a Generative AI Data Scientists, Software and App Developer, Machine Learning Engineer and Researcher, Data Engineer, and Tech Lead or Manager -Located in the US/Canada/ Brazil, Europe -Compensation: Earn up to $600 USD in total + bonuses Sign up here to take the screener and see if you qualify: https://hubs.li/Q03C7kz40 You will receive an email with next steps and screener details as soon as you sign up using the above link. By signing up, you not only become eligible for this study but also open doors to potential participation in other paid studies in the future.

This position is part of the VISN Clinical Resource Hub (CRH) Virtual Psychotherapy Program for Caregivers (VPPC) Team, located in VISN 21. Staff within the CRH provide interprofessional services to VISN facilities that are underserved or experiencing gaps in clinicians. Conducts mental health assessments and treatment plans and psychotherapy to caregivers, families, couples, and groups to treat a variety of mental health diagnoses and disorders. Works closely with the Program of Comprehensive Assistance for Family Caregivers (PCAFC), the Program of General Caregiver Support Services (PGCSS), and other CSP staff to ensure a seamless transition to appropriate services for caregivers. Coordinates with the Substance Abuse Treatment Program, PTSD program, M2VA, and other Behavioral Health services as needed. Provides crisis intervention for caregivers in Behavioral Health in the outpatient setting. Performs other related duties as assigned.