Clinical Research Manager - Personalized Medicine Institute

Job Description

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.


Roles & Responsibilities:


With significant professional discretion, judgment and autonomy, manage the planning, data collection and data analysis for multi-faceted, multi-center research projects for clinical and translational studies in inflammatory bowel disease. Analyze and evaluate clinical data gathered during research and ensures compliance with protocol and overall clinical objectives. Independently manage all aspects of project activities including timelines and deliverables, and support staff. Conducts and train others on standard operating procedures for samples, data and regulatory compliance. Reviews and presents data for publication or presentation.

Duties and Responsibilities: 

  • Carry out research within the scope of the established study protocols, while adhering to all human subjects regulations as defined by Institutional Review Boards and the federal mandates pertaining to human subject research
  • Lead efforts in developing and managing case report forms overseeing the organization and implementation of new research study protocols and procedures, which involves creation of data forms and databases, planning and coordination with staff, identifying obstacles encountered during initial study phases- monitor protocol effectiveness, and developing acceptable resolutions to such obstacles/modifying protocols as necessary
  • Independently utilize research skills and proper judgment to complete specific research project objectives: coordinating patient enrollment through developing relationships with physicians and patients, determine subject eligibility based on understanding of protocol and research goals, and monitoring all aspects of study subject recruitment, including reaching out to research participants for data and biospecimen collections
  • Efficiently track and monitor mechanisms for the recruitment of new and established patients. Assure high levels of study subject involvement and develop mechanisms for efficient, ongoing recruitment of key study subjects. Develop forms, questionnaires and the application of research techniques; write procedure manuals for data collection and coding
  • With thorough working knowledge of regulatory and research guidelines review protocols and protocol amendments, address protocol implementation issues, and develop, implement and deliver orientation and continuous compliance training to all members of the research team. Maintain all records of training received for compliance purposes and evaluate continuous training needs
  • Responsible for the documentation and transmission of study data. Ensure that report forms are accurately documented and completed in a timely manner. Performs descriptive and multivariate statistical analyses of data, using computer software. Designs and implements quality control measures to ensure accurate collection and processing of data. Analysis of data and dissemination of results to funding agencies, and ensuring subject recruitment and follow-up are completed per protocol in accord with study timeline
  • Design and implement quality control measures to ensure accurate collection and processing of data and dissemination of results to funding agencies, ensuring subject recruitment and follow-up are completed in accord with study timeline
  • Contribute in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts. Write relevant reports and assist with presentations related to the research activity which includes, but is not limited to, grant renewal, initiation of new grants, reports to funders, letters of collaboration, responses to participation on conference calls and other matters, with little assistance
  • Attend weekly meetings related to ongoing research protocols and generate weekly reports of subject activities and study progress. Update faculty and research staff to ensure the integrity of ongoing research and data production
  • Collaborating with the NIDDK IBD Genetics Consortium Data Coordinating Center to manage data collection for research projects and develop procedures for database entry
  • Provide strong leadership and management to oversee and coordinate staff members. Train and monitor staff in running protocols including the establishment of timelines for project milestones and project completion
  • Manage day to day operations of the laboratory including equipment maintenance and order supplies
  • Understand the overall goals of the project and integrate samples and data between members of a multidisciplinary team
  • Perform other related duties as determined by supervisors
  • Master's degree in health or research related discipline and two years of related work experience in a similar job family
  • Experience must indicate ability to work with minimal supervision in a team atmosphere and receptiveness to direction
  • Ability to effectively, efficiently, and independently work under pressure and set priorities among multiple competing tasks, with limited supervision
  • Experience in research setting, with databases, spreadsheets, and statistical methods; NIH grant experience
  • Demonstrated ability to report on the status of project deliverables and draft and submit project updates. Proven ability to schedule and coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline. Extremely organized and detailed oriented
  • Strong clinical and analytical skills. Demonstrated ability to create and follow research project related supporting documents. Proven ability to evaluate and assess subject's suitability for inclusion into studies, obtain informed consent, determine patient eligibility and coordinate patient enrollment
  • Excellent time management and organizational skills, strong interpersonal skills with proven ability to communicate effectively, and highly self-motivated, independent, consistent, and reliable
  • Ability to work successfully as a team member, at various levels of organizational responsibility, for different projects
  • Intermediate proficiency with Microsoft Office, some working knowledge of REDCap and programming languages such as R
  • Basic laboratory skills including pipetting, cell culture and PCR
Strength Through Diversity

The Mount Sinai Health System believes that diversity is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize medicine together.


We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care. 


Explore more about this opportunity and how you can help us write a new chapter in our story! 

Who We Are

Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.


Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.


The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation. 


EOE Minorities/Women/Disabled/Veterans 


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