Site Visit Lead/Investigator

General Dynamics Information Technology

1d•Hybrid

About The Position

The Site Visit Lead/Investigator serves as a key clinical professional responsible for planning, conducting, and documenting site visits, both routine and triggered by patient safety investigations, at OPTN member institutions. These site visits can be onsite or virtual and are designed to monitor compliance with OPTN bylaws and policies, ensuring patient safety, data accuracy, and adherence to federal healthcare regulations. This role requires strong expertise in compliance monitoring, clinical process evaluation, investigations, and stakeholder management. Site Visit Leads/Investigators may work collaboratively with Subject Matter Experts (SMEs) during site visits and may surge to assist with ongoing patient safety investigations as needed.

Requirements

A Bachelors degree is required
Requires at least 5 years in compliance, project management, quality improvement, auditing, or investigations within healthcare or regulatory environments
Requires a background in clinical quality, patient safety, or experience in a transplant-related field.
Strong understanding of federal, state, and local regulations
Knowledge of transplant regulations and policies.
Clinical experience is required, particularly in patient safety, compliance or transplant related environments
Strong analytical and communications
Medical chart review
Strong organizational skills to manage schedules and audit logistics
Must be able to travel to member organizations throughout the country (up to 25% of the time)
Must be able to obtain a Public Trust clearance

Nice To Haves

Registered Nurse (RN) or Social Worker (MSW) preferred

Responsibilities

Plan and conduct both routine and investigative onsite and desk audits of transplant hospitals, Organ Procurement Organizations (OPOs), and other OPTN member institutions.
Evaluate adherence to OPTN bylaws, policies, and regulations.
Assess defined processes at OPTN member institutions to confirm compliance with expected standards.
Document findings and recommend corrective actions where necessary.
Develop and implement detailed site visit plans, including agendas, schedules, checklists, and team rosters.
Coordinate logistics with HRSA, site visit teams, and OPTN member organizations to ensure timely and effective visits.
Ensure required access to staff, documents, workflows, and facilities at OPTN member organizations.
Collaborate with HRSA and the OPTN Logistics contractor to arrange travel and participant logistics for Subject Matter Experts (SMEs) accompanying site visits.
Conduct thorough and timely site visits, whether virtual or onsite, ensuring all activities, such as interviews, observations, and process evaluations, are accurately documented.
Collect and compile evidence, including medical records, clinical workflows, interviews, and observations, to support case reviews and final decisions.
Ensure site visits are unbiased and free of conflicts of interest.
Draft and finalize comprehensive site visit reports summarizing findings, actions, and next steps.
Maintain detailed records of site visit activities, including participant lists, notes, transcripts, recordings, and supporting documentation.
Submit final site visit reports and supporting documentation to stakeholders within documented deadlines.
Collaborate with HRSA, OPTN Committees, site visit teams, and OPTN member organizations to ensure effective and fair reviews.
Support proactive identification and monitoring of conflicts of interest among site visit participants.
Serve as the primary point of contact for external stakeholders during site visits.
Track site visit progress and status, integrating updates into broader case management tools and reports.
Align site visit outcomes with ongoing case reviews and oversight processes, ensuring comprehensive follow-through and documentation of corrective actions, escalations, or additional monitoring requirements.

Benefits

Growth: AI-powered career tool that identifies career steps and learning opportunities
Support: An internal mobility team focused on helping you achieve your career goals
Rewards: Comprehensive benefits and wellness packages, 401K with company match, and competitive pay and paid time off
Flexibility: Full-flex work week to own your priorities at work and at home
Community: Award-winning culture of innovation and a military-friendly workplace
variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match.
full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave.
typically provides new employees with 15 days of paid leave per calendar year to be used for vacations, personal business, and illness and an additional 10 paid holidays per year.
Paid leave and paid holidays are prorated based on the employee’s date of hire.
The GDIT Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees.
other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available.