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.
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. A primary focus of the role will be on understanding and ensuring compliance with all laws, policies, 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.
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.
- Develops, conducts training on, oversees the implementation of, and supervises adherence to clinical research policies and procedures.
- Provides direct support to the Clinical Research leads in the ongoing management of all clinical research awards, programs, financials, and staffing.
- Liaises with the Institute's central administration and other relevant departments to ensure successful negotiation, setup, maintenance, and close-out of all mechanisms of clinical research awards.
- 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.
- Oversees all Institutional Review Board (IRB) and other relevant compliance-related records.
- Monitors all clinical research for reportable events and coordinates the internal and external documentation.
- Provides technical assistance in the development of investigator-sponsored clinical research.
- Reviews and reports on clinical research expense and revenue streams.
- Serves as the primary point person to ensure the accurate setup and maintenance of clinical research protocols, budgets, and records.
- Drive revenue cycle results on behalf of department management.
- 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.
- Provides full transparency to research teams, management, and leadership.
- Direct kick-off meeting for projects to provide clear guidance.
- Coordinates with the Institute's central administrative team to guide the progress of all award and other administrative documentation.
- Monitors inventory of materials and supplies necessary for clinical research.
- Applies expertise and independent judgement to provide initial review of agreements, budgets and pertinent documents.
- Prepares correspondences with sponsors and coordinates their internal review.
- Develop relevant administrative or financial reports and dashboards for clinical research.
- Serves as a backup for and supports Institute-wide sponsored programs administration.
- 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.
Management Responsibilities:
- No direct management responsibilities; may be asked to train, provide feedback, and conduct quality assurance to other staff.
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.
- Knowledge of principles and processes for providing excellent customer service.
- Knowledge of all applicable WWH policies and procedures.
- Excellent oral and written communication skills.
- Knowledge of healthcare information systems.
- Ability to maintain records and information in an accurate, timely and confidential manner.
- Ability to adapt to changes in the service delivery model.
- Flexibility to work various shifts.
- Commitment to health equity.
Role Specific- Knowledge, Skills and Talents Required:
- Highly developed oral and written communication skills.
- Full working knowledge of and experience with clinical research administration.
- Fundamental technical understanding of and experience working with federal regulations relevant to research.
- Ability to communicate effectively with legal and accounting experts.
- Understanding of clinical trials management systems.
- Familiarity with regulatory issues in the management of clinical trials.
- Experience with billing and payment reconciliation.
- Ability to prepare accurate, concise and comprehensive reports.
- Strong attention to detail and excellent organizational skills.
- Proficiency in the use of Excel.
Education and Experience Required:
- Bachelor's degree or at least 5 years of equivalent experience required.
- A minimum of 5 years of relevant work experience in a clinical, healthcare, or health research setting.
- Certified in clinical research administration or the ability to begin a program to obtain certification within 6 months of hire.
- Demonstrated commitment to research to achieve health equity.
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.
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.
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