White Plains Hospital Inc
Research Manager, Ambulatory Cardiology
White Plains Hospital Inc, Yorktown Heights, New York, United States
Position 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. It will work collaboratively with faculty, study team members, clinical trial experts, representatives from pharmaceutical companies, federal agencies, and other research organizations. The role requires close interactions with investigators, research coordinators, departmental and hospital administrative staff, and other ancillary departments involved in clinical research operations.
Responsibilities
Work with Principal Investigator(s) to develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with 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 the 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.
Develop a preliminary draft budget, submit to the Director/Principal Investigator, review sponsor‑proposed budget, recommend changes, and manage the research billing compliance process.
Maintain departmental calendar, schedule meetings, prepare agenda, and take meeting minutes.
Coordinate and schedule interim monitoring visits (IMVs) with Principal Investigators, pharmacy, internal departments, and study sponsors.
Collect and audit patient information for the research projects, including abstraction of laboratory or diagnostic test results and adverse drug reactions.
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 regulatory tracking databases; coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.
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 WPH SOPs.
Establish and maintain regular communication with the study team, sponsor, and regulatory agencies to ensure all required information is communicated; serve as facilitator for study status, safety issues, upcoming protocol amendments, consent changes, and training.
Maintain working knowledge of current regulations, regulatory guidance and local policies; perform 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.
Develop and maintain a high level of customer service with staff, colleagues, superiors, patients, hospital visitors, vendors, representatives of other institutions, and governmental agencies.
Perform all other related duties as assigned.
Essential Functions
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 WPH SOPs.
Establish and maintain regular communication with the study team, sponsor, and regulatory agencies.
Serve as facilitator for study status, safety issues, upcoming protocol amendments, consent changes, and training.
Maintain working knowledge of regulations and perform regulatory‑based training.
Present regulatory status updates at research meetings.
Experience
Minimum of 10+ years of research administration experience.
Experience submitting IRB applications (new and amendments).
Knowledge of clinical trial federal, state, and local regulations.
Extensive knowledge of Microsoft Office (Word, Excel, Adobe Acrobat) including Tracked Changes functionality.
Excellent interpersonal and communication skills.
Education
Bachelor’s degree in relevant field preferred.
Research certification (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, solving unexpected problems under pressure.
Organizational Operations: working with cross‑functional teams (e.g., HR, IT, finance).
Physical/Mental Demands and Work Environment
May be exposed to chemicals necessary to perform required tasks. Hazardous chemicals referenced in the hospital’s SDS database are accessible via the hospital’s intranet.
Primary Population Served All populations
Seniority Level Director
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industries Hospitals and Health Care
#J-18808-Ljbffr
Responsibilities
Work with Principal Investigator(s) to develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with 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 the 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.
Develop a preliminary draft budget, submit to the Director/Principal Investigator, review sponsor‑proposed budget, recommend changes, and manage the research billing compliance process.
Maintain departmental calendar, schedule meetings, prepare agenda, and take meeting minutes.
Coordinate and schedule interim monitoring visits (IMVs) with Principal Investigators, pharmacy, internal departments, and study sponsors.
Collect and audit patient information for the research projects, including abstraction of laboratory or diagnostic test results and adverse drug reactions.
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 regulatory tracking databases; coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.
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 WPH SOPs.
Establish and maintain regular communication with the study team, sponsor, and regulatory agencies to ensure all required information is communicated; serve as facilitator for study status, safety issues, upcoming protocol amendments, consent changes, and training.
Maintain working knowledge of current regulations, regulatory guidance and local policies; perform 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.
Develop and maintain a high level of customer service with staff, colleagues, superiors, patients, hospital visitors, vendors, representatives of other institutions, and governmental agencies.
Perform all other related duties as assigned.
Essential Functions
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 WPH SOPs.
Establish and maintain regular communication with the study team, sponsor, and regulatory agencies.
Serve as facilitator for study status, safety issues, upcoming protocol amendments, consent changes, and training.
Maintain working knowledge of regulations and perform regulatory‑based training.
Present regulatory status updates at research meetings.
Experience
Minimum of 10+ years of research administration experience.
Experience submitting IRB applications (new and amendments).
Knowledge of clinical trial federal, state, and local regulations.
Extensive knowledge of Microsoft Office (Word, Excel, Adobe Acrobat) including Tracked Changes functionality.
Excellent interpersonal and communication skills.
Education
Bachelor’s degree in relevant field preferred.
Research certification (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, solving unexpected problems under pressure.
Organizational Operations: working with cross‑functional teams (e.g., HR, IT, finance).
Physical/Mental Demands and Work Environment
May be exposed to chemicals necessary to perform required tasks. Hazardous chemicals referenced in the hospital’s SDS database are accessible via the hospital’s intranet.
Primary Population Served All populations
Seniority Level Director
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industries Hospitals and Health Care
#J-18808-Ljbffr