Research Manager, Ambulatory CardiologyPosition Summary
This position will provide operational leadership, direction and oversight for the day-to-day Site and Regulatory operations of the WPH/Hudson Valley Cardiology research site. This position will work collaboratively with a variety of personnel at all levels including faculty and study team members of WPH and external institutions, clinical trials experts, representatives from the pharmaceutical companies, federal agencies and other research organizations. This position requires close interactions with Investigators, Research Coordinators, Departmental and Hospital Administrative staff and other ancillary departments involved in clinical research operations.
Work with Principal Investigator(s) to develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with Food and Drug Administration (FDA), local and central Institutional Review Board (IRB) policies.
Assure all site documents, including SOPs and administrative files, are maintained in audit-ready condition.
Remain informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.
Assist in obtaining initial documents for clinical trials procurement and site selection.
Develop the consent form, HIPAA authorization form, and other IRB-required forms specific to each protocol.
Manage and schedule new study initiation process and provide regulatory guidance/support throughout the duration of the project.
Revise submissions in response to identified problems and resolve issues in a timely manner; inform cardiology research team on revisions and remedies.
Report pertinent safety data, Adverse Events (AEs), Serious Adverse Events (SAEs), and protocol deviations to the IRB.
Maintain current and accurate documentation in the electronic regulatory binder(s).
Participate in required teleconferences, on-site meetings and off-site investigator meetings, as required.
Financial Management – develops a preliminary draft budget and submit to the Director/Principal Investigator. Reviews sponsor-proposed budget for adequate coverage and recommend changes as appropriate. Manages the research billing compliance process.
Maintains departmental calendar, schedule meetings, prepares agenda, takes meeting minutes.
Coordinates and schedules interim monitoring visits (IMVs) with Principal Investigators PIs, pharmacy, internal departments and study sponsors.
Data/Chart Reviews - Responsible for collecting and auditing patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, adverse drug reactions, etc.), or data collection from outside physicians’ offices. Conducts study visits, obtains and documents information within the time frame specified.
Essential Functions and Responsibilities Includes the Following:
- Understands and adheres to the WPH Performance Standards, Policies and Behaviors.
- Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for IRB review and approval. Prepares, maintains and organizes regulatory files for each assigned study in compliance with study sponsor requirements. -Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion. -Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.
Clinical Trial Management:
- Track and manage assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress. Coordinate study agreements and budgets with Research Administration and the sponsor. Maintain source documents and subject files in accordance with White Plains Hospital’s (WPH) Standard Operating Procedures (SOPs).
Stakeholder Engagement:
- Establish and maintain regular communication with the study team including PI’s, study sponsor, and applicable regulatory agencies to ensure all required information is communicated. Serve as facilitator for study team and sponsor with regard to study status information, safety issues, upcoming protocol amendments and consent changes and applicable protocol training.
Leadership and Professionalism:
- Maintain working knowledge of current regulations, regulatory guidance and or local policies. Performs regulatory based training and implementation of new or revised regulations, guidance and/or local policy. Present regulatory status updates at applicable research meetings.
- Protocol oversight; monitoring and reporting of study events; data collection; adherence to study protocols; in-service education of physicians, nurses, and support staff to protocol requirements; coordinate research activities
- Develops and maintains a high level of customer service with staff, colleagues, superiors, patients, hospital visitors, vendors, representatives of other institutions and governmental agencies.
- Performs all other related duties as assigned.
Education & Experience Requirements
Experience:
- Minimum of 10+ years of research administration experience required.
- Experience in submitting IRB applications (new and amendments) required.
- Knowledge of clinical trial federal, state and local regulations required.
- Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked Changes functionality required.
- Excellent interpersonal and communication skills required.
Education:
- Bachelor’s degree in relevant field preferred.
- Research certification (e.g. RAPS, ACRP, SoCRA or equivalent) required.
- Current CITI training certification.
Core Competencies
- Leadership and People Management: supervising or mentoring staff, exposure to recruitment, onboarding or performance reviews.
- Project and Operational Management: planning and executing projects from start to finish, improving processes, workflows and efficiency
- Communication and Relationship-Building: running meetings, writing reports or updates, building trust with team members, peers and higher-ups.
- Change and Problem-Solving Experience: handling change management (new systems, restructuring, policies), solving unexpected problems under pressure
- Organizational Operations: Working with cross-functional teams (e.g., HR, IT, finance).
Physical/Mental Demands/Requirements & Work Environment
- May be exposed to chemicals necessary to perform required tasks. Any hazardous chemicals the employee may be exposed to are listed in the hospital’s SDS (Safety Data Sheet) data base and may be accessed through the hospital’s Intranet site (Employee Tools/SDS Access). A copy of the SDS data base can also be found at the hospital switchboard, saved on a disc.
Primary Population Served
All populations
PIcc9d9a3283cd-37437-38545851
