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New York Medical College
Clinical Research Project Manager
IRB
Edtech.com's Summary
New York Medical College is hiring a Clinical Research Project Manager to oversee and manage all aspects of ongoing clinical research studies. The role includes monitoring study metrics, coordinating between sponsors and research teams, managing research data, and ensuring adherence to protocols and regulations.
Highlights
- Manage contracts, study progress reports, orders, and supplies for clinical trials.
- Monitor study site performance using standard management tools and report progress.
- Serve as liaison between sponsors, investigators, research coordinators, and senior management.
- Develop and implement SOPs, patient acquisition plans, and research workflow protocols.
- Handle research data generation, clinical data analysis, and regulatory interfaces with IRB, ORA, and hospital offices.
- Proficient in Electronic Data Capture (EDC) systems, REDCap preferred, and MS Office applications including Word, Excel, and Access.
- Requires a Bachelor’s degree in biology, mathematics, computer science, natural sciences or related fields.
- Minimum two years of relevant professional experience with demonstrated multi-site research study management skills.
- CITI certification mandatory; strong communication, organizational, and problem-solving skills required.
- Salary range: $56,000 to $70,000 per year.
Clinical Research Project Manager Full Description
Overview:
The candidate will report to the Vice President of Research. Incumbent will manage all aspects of ongoingresearch studies. Attention to detail, self-starter, well organized as well as good communication skills. Applicant must adhere to Patient confidentially. The individual will be responsible for the oversight of studies conducted out of the clinical trials unit, and as such, will be responsible for contracts, oversee the research coordinators and study progress reports, orders, and other tasks as needed.
Responsibilities:
Responsibilities:
- Monitor study metrics and site performance using standard study management tools.
- Oversee the individual study progress over duration of each project.
- Direct liaison between sponsors/investigators and the research coordinator or Vice President
- Establish research data and work flow plans.
- Contribute to the development and implementation of SOPs, project-specific procedures, and technical guidance documents, patient acquisition plans, etc.
- Direct establishment of clinical and analytical study related protocols and documents, as well as research/clinical data analysis.
- Manage the orders, sample deliveries and supplies required for each study.
- Interface with investigational sites, clinical consultants, and labs.
- Management of research data sites and renewal terms related with each study and CTU functions.
- Direct all aspects of research data generation and analysis including external site clinical studies and internal analytical studies.
- Drive internal communication, including timelines, budget, progress, and project needs for clinical trials to product teams and senior management.
- Interface with ORA, IRB, WMC and other pharmaceutical/hospital research offices
Qualifications:
Education requirement: Bachelor's degree in biology, mathematics, computer science, natural sciences or related areas.
Licenses or certifications: CITI
Technical/Computer skills:
• Ability to use a combination of validated Electronic Data Capture (EDC) systems and/or other
internal or commercial software tools and proven ability to learn and apply new software quickly
as projects require. Familiarity with REDCap preferred.
• Strong IT skills, including excellent knowledge of various software programs and packages
including MS Word, Excel, Access
Prior experience: Minimum of two years of related professional experience
Skills:
• Ability to multi-task and meet established deadlines.
• Ability to work effectively both as part of a project team and independently is essential
• Excellent oral and written English communication skills.
• Proven experience using data management systems, tools and processes to support multi-site, multimode research studies.
• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to
required guidelines, SOPs and client expectations.
• Good organizational and analytical/problem-solving skills with strong attention to detail.
• Ability to work productively with minimal supervision.
• Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs.
• Strong customer focus and excellent interpersonal skills.
To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status.
Minimum Salary: USD $56,000.00/Yr. Maximum Salary: USD $70,000.00/Yr.
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