About Whitman-Walker Whitman-Walker envisions a society where all persons are seen for who they are, treated with dignity and respect, and afforded equal opportunity to health and wellbeing. Through care, advocacy, research, and education, we empower all persons to live healthy, love openly, and achieve equality and inclusion. For over 50 years, we have been meeting the needs of our communities with the endless dedication of our diverse teams. About Whitman-Walker Institute Whitman-Walker Institute's (the Institute ) mission is to expand the body of knowledge needed to strengthen Whitman-Walker's programmatic foundation of care, advocacy, research and education. The Whitman-Walker Institute focuses on the strategic integration of research, policy, and education to improve the health and wellbeing of underserved communities nationwide, particularly LGBTQ people and people living with HIV. We do so through innovative research, effective stakeholder education, and shaping the systems of care that erect barriers to good health. The Institute is a part of the Whitman-Walker Health System. The Institute also supports Whitman-Walker Health in their mission of caring for the community, providing mission-critical support to Whitman-Walker Health through expanded research, education, policy and advocacy initiatives. Job Summary The Clinical Research Administrative Specialist will serve as the primary point person for the Institute to coordinate all administrative, contractual, financial, and regulatory/compliance aspects of Whitman-Walker Institute's portfolio of federally- and industry-sponsored clinical research, including feasibility requests, protocol development and approvals, budget and contract negotiation, site and monitoring visits, regulatory compliance, and fiscal oversight and reporting. Given the heavily regulated nature of clinical research, a primary focus of the role will be on understanding and ensuring compliance with all laws, polices, regulations, and terms/conditions as they apply to each unique study and supporting the Principal Investigators and project teams in maintaining ongoing compliance. Additionally, the role will involve a significant financial and contractual focus, both in terms of the processing of new clinical research awards and agreements to ensure the best possible fiscal and risk management positions of the Institute and to support the management of the ongoing financial viability of the clinical research program through timely and thorough invoicing, expense tracking, and financial reporting. The Clinical Research Administrative Specialist will also ensure compliance with all licensing, credentialing, and other regulatory requirements for both staff and facilities/equipment within the clinical research program and ensure the availability of appropriate clinical materials and supplies. Core Whitman-Walker Primary Essential Duties:
- Performs and behaves in accordance with Whitman-Walker's mission, cultural norms and core values of dignity, respect, affirmation, and humility.
- Maintain a respectful, non-judgmental, and compassionate manner with patients/clients/staff.
- Demonstrate excellent customer service by identifying and exceeding customer requirements.
- Adhere to Whitman-Walker policies and procedures, with special attention given to HIPAA requirements.
- Maintain data integrity through conscientious use of relevant tools and employing a system of checks and balances.
- Demonstrate organizational skills necessary to multi-task, meet deadlines and re-prioritize as needed.
- Participate in organizational quality and performance improvement activities.
Role Specific Primary Essential Duties:
- Supports Institute leadership and management by monitoring, investigating, reporting, and enforcing compliance with policies and procedures impacting clinical research proposals, awards, and agreements, with an emphasis on sponsor terms and conditions, budget and reimbursement structure, federal regulations (e.g., Food and Drug Administration requirements), and all applicable laws and regulations in collaboration with Finance and Compliance/General Counsel
- Develops, conducts training on, oversees the implementation of, and supervises adherence to clinical research policies and procedures among both management and non-management clinical research staff; investigates and documents incidents of non-compliance, recommends and oversees the implementation of corrective action plans
- Provides direct support to the Clinical Research leads in the ongoing management of all clinical research awards, programs, financials, and staffing, including credentialing of clinical staff
- Liaises with the Institute's central administration and other relevant departments (e.g., Finance, General Counsel) to ensure successful negotiation, setup, maintenance, and close-out of all mechanisms of clinical research awards and other sponsored activities to mitigate real or perceived risk to the organization and retain the confidentiality of all proprietary information and potential intellectual property.
- Maintain the ongoing certification, credentialing, and other regulatory approvals for all facilities, equipment, and instruments used within the clinical research program
- Oversees all clinical research pharmacy operational and personnel needs related to clinical studies and lab facilities
- Leads/attends all site and monitoring visits
- Ensures the ongoing compliance of all clinical research staff with relevant federal, sponsor, and agreement-specific regulations, including the ongoing and timely documentation of all relevant certifications and assurances (e.g., human subjects protections, conflict of interest), as well as CV's/resumes, all licensure and other requirements for clinicians performing research duties
- Oversees all Institutional Review Board (IRB) and other relevant compliance-related records, coordinating all submissions, modifications, continuing reviews, and other necessary actions
- Monitors all clinical research for reportable events and coordinates the internal and external documentation, submission, and review of such records. Provides Institute Leadership summary of events and interviews of appropriate individuals (can include members of management), cause for reporting and suggested corrective action.
- Provides technical assistance in the development of investigator-sponsored clinical research and manages proposal preparation, negotiation, and execution
- Reviews and reports on clinical research expense and revenue streams to support optimization of clinical research budgeting and prepares projections for use in departmental budgeting processes
- Serves as the primary point person to ensure the accurate setup and maintenance of clinical research protocols, budgets, and records within the clinical trials management system as well as all electronic data capture systems maintained by sponsors, in close coordination with project leads and other staff
- Drive revenue cycle results on behalf of department management by configuring budgets, generating and processing invoices, reconciling payments, and developing routine reports for the fiscal oversight of clinical research
- Assigns duties to managerial and non-managerial staff to ensure ongoing regulatory compliance
- Maintains accurate and up-to-date records of each clinical trial/research project and its status within relevant databases, file servers, and other shared systems
- Provide full transparency to research teams, management, and leadership by including appropriate individuals in communication and streamlining processes
- Direct kick-off meeting for projects to provide clear guidance of final decision of sponsor negotiations, expectations, accountability and development of communication logs.
- Coordinates with the Institute's central administrative team to guide the progress of all award and other administrative documentation through internal review and routing procedures, ensuring timely completion to meet all relevant deadlines
- Monitors inventory of materials and supplies necessary for basic, translational, and clinical research and ensures ongoing availability
- Applies expertise and independent judgement to provide initial review with red-lined comments on agreements, budgets and pertinent documents to be further reviewed by administrative leadership and legal counsel
- Prepares correspondences with sponsors and other relevant external bodies and coordinates their internal review by relevant stakeholders to ensure timely responsiveness
- Develop relevant administrative or financial reports and dashboards for clinical research, as requested
- Serves as a backup for and supports Institute-wide sponsored programs administration, as requested
- Other duties as assigned
Budget Responsibilities:
- Responsible for revenue cycle grants management
- Coordinates organizational and project budgets
- Supports oversight of all clinical research project budgets/accounts in collaboration with Institute leadership and manages budget negotiation, setup, and billing for assigned studies/protocols.
Management Responsibilities:
- No direct management responsibilities; may be asked to train, provide feedback, and conduct quality assurance to other staff on relevant areas of responsibility
Core Whitman-Walker Knowledge, Skills, and Talents Required:
- Ability to work independently with minimal supervision.
- Ability to manage time and effort to meet strategic objectives and complete work.
- Knowledge of principles and processes for providing excellent customer service, both internal and external.
- Knowledge of all applicable WWH policies and procedures.
- Excellent oral and written communication skills.
- Knowledge of healthcare information systems with the ability to adapt to new insurance eligibility, electronic medical record, and population health platforms.
- Ability to maintain records and information in an accurate, timely and confidential manner.
- Ability to adapt to changes in the service delivery model, re-prioritizing as necessary.
- Flexibility to work various shifts, including afternoon and evening shifts as necessary.
- Flexibility to work within the organizations various locations as necessary.
- Commitment to health equity.
Role Specific- Knowledge, Skills and Talents Required:
- Highly developed oral and written communication skills, including the ability to function efficiently as part of a multidisciplinary team.
- Full working knowledge of and experience with clinical research administration and grant/contract/agreement negotiation and management.
- Fundamental technical understanding of and experience working with federal regulations relevant to research, with an emphasis on those applicable to clinical research and drug trials (e.g., Code of Federal Regulations, Food and Drug Administration)
- Ability to communicate effectively with legal and accounting experts and successfully convey technical information to programmatic leads
- Understanding of clinical trials management systems and the ability to quickly develop expertise in new systems.
- Familiarity with regulatory issues in the management of clinical trials and other clinical research designs.
- Experience with billing and payment reconciliation, preferably within a clinical research context.
- Ability to prepare accurate, concise and comprehensive reports.
- Ability to maintain information in an accurate, timely, and confidential manner.
- Strong attention to detail and excellent organizational skills
- Proficiency in the use of Excel and ability to quickly learn the use of new project/financial management platforms
- The ability to handle multiple tasks simultaneously and shift priorities seamlessly to meet ongoing needs and deadlines.
Education and Experience Required:
- Bachelor's degree or at least 5 years of equivalent experience required; relevant graduate-level training beyond this degree in a relevant field (e.g., public administration, research administration) may be considered as additional years of experience.
- A minimum of 5 years of relevant work experience in a clinical, healthcare, or health research setting, with at least 2 years within research or clinical trials administration.
- Certified in clinical research administration or the ability to begin a program to obtain certification within 6 months of hire from a relevant professional organization.
- Demonstrated commitment to research to achieve health equity and experience working with a broadly diverse population and ability to work harmoniously with diverse groups of individuals.
The above job description is designed to indicate a general sense of the duties and expectations of this position. It is not to be interpreted as a comprehensive inventory of all duties and responsibilities required. As the nature of our business demands change, so too, may the duties and responsibilities of this position. You may be required to perform other duties as requested, directed, or assigned. Whitman-Walker is an equal employment opportunity employer and does not discriminate against applicants, its employees or former employees based on race, color, religion, gender, marital status, sexual orientation, national origin, age, disability, veteran status, and gender identity. For accommodation in the application process, please contact Human Resources.