Description     General Summary

The research scientist in the Clinical Sciences in the Division of Rheumatology will join the lab of Dr. Katherine Liao.The research scientist will work closely with Dr. Liao to oversee management of lab projects with a focus on patient-oriented studies involving recruitment and studies conducted as part of the VERITY Bioinformatics Core.General roles include overseeing and participating in patient recruitment, as well as collaborative projects between the Core and other collaborators both within and outside of BWH.The research scientist will also oversee coordination of patient recruitment, data and analyses (clinical focus on rheumatoid arthritis and cardiovascular disease), application of bioinformatics and statistical pipelines supported by the Core as well as design and oversee analyses for clinical research for a broad range of conditions. They will also oversee training and management of the research staff.

Primary Responsibilities

Responsibilities include working closely with the team including fellows, analysts, to oversee the conduct of projects by the team ranging from patient recruitment studies to analyses in large databases studies, assist with oversight of Core resources such as code books and data mappings, preparing tables and figures for reports, and overseeing statistical analyses ranging from summary statistics to applying machine learning approaches.

The position requires the ability to develop an in-depth understanding of our research questions as well as the data and data structures. Willingness to learn new skills and ability to work in a team setting is essential.

The position includes    coordinating and carrying out study-related activities such as designing data collection instruments and programming study databases, organizing, and maintaining various meetings/agendas, assisting with hiring and training of new staff, as well as creating, managing, and maintaining several internal review board protocols.The role also includes learning how to apply    existing lab bioinformatics pipelines.The role includes contributing to grant proposals, manuscripts, publications and abstracts, as well as reports and presentations.
Qualifications
Qualifications

*   Master's degree or higher in an analytic field, such as biostatistics, statistics, or epidemiology is required; PhD is preferred

*   At least two years of relevant work experience is required

*   Experience working with R programming language is required and essential to the position

*   Experience working in Excel

*   Previous experience in project management in the area of patient recruitment is preferred

Skills, Abilities, Competencies Required

*   Must have interpersonal skills to interact effectively with persons of all levels

*   Excellent problem solving, analytical and communication (written and verbal) skills

*   R programming language is required

*   SAS programming language is preferred (SAS BASE, STAT, MACRO)

*   Knowledge of computerized data entry programs such as MS Access

*   Must be able to prioritize and organize work responsibilities in order to meet deadlines

*   Must possess a great deal of integrity to maintain confidentiality

*   Must demonstrate accuracy in maintaining data

*   Must be able to make independent judgments under general supervision for the above mentioned job duties and responsibilities

*   Knowledge of SQL programming languages preferred but not required

*   Experience implementing machine learning algorithms preferred but not required

*   Evidence of potential for scientific creativity, original thought

*   Able to exercise independent judgment and leadership

*   Able to work on complex, large projects

*   Able to determine project objectives and approach

*   Ability to work independently as well as being a team player

*   Strong attention to detail
EEO Statement    BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Primary Location  :  MA-Boston-BWH Longwood Medical Area    Work Locations  :   BWH Longwood Medical Area    75 Francis Street    Boston  02115     Job  :  Research    Organization  :  Brigham & Women's Hospital(BWH)    Schedule  :  Full-time    Standard Hours  :  40    Shift  :  Day Job    Employee Status  :  Regular    Recruiting Department  :  BWH DOM Rheumatology    Job Posting  :  Nov 27, 2024
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General Summary We are seeking an intellectually curious and highly organized individual with clinical trial interest/experience to serve as a Research Scientist in the Center for Clinical Investigation (CCI), and collaboratively with PIs from Massachusetts General Hospital and University of Texas Southwestern. The candidate will work with Department Managers, the Finance Manager, and Principal Investigators and under general supervision from the Research Operations Director. The mission of the CCI is to strengthen the culture for clinical research at the Brigham and Women's Hospital by building services helpful to clinical investigators and facilitating the success of individual investigators. A specific exciting multi-year clinical trial in startup phase relates to antibiotic allergy and is funded by the National Institutes of Health. The Research Scientist will play a key role in the execution of this study that is being conducted in about 6 US sites. When applying, please include a cover letter along with your resume For more information regarding our group, please visit Center for Clinical Investigation. The Research Scientist will be responsible for developing and maintaining the infrastructure of a multicenter clinical trial by supporting the design, planning, and management of the clinical trial. The position plays a key role in conducting research projects, obtaining funding, writing or other recognition. He/she is highly competent, experienced and/or recognized in their field, their contribution is essential to the conceptual/scientific success of the project. Principal Duties and Responsibilities: Provides strong leadership as a liaison between the investigators, sites, and sponsors. This includes: <ul><li>Developing a plan for all projects and ensuring follow-up on all discussions, and requesting an update on projects.</li><li>Meeting with the research team regularly to review trial projects, timelines and action items</li><li>Contribute to the strategic development of the multicenter trial </li><li>Develops and convenes trial oversight committees such as Steering Committee, Executive Committee, and Advisory Boards (as needed) and run meetings as needed</li><li>Leads or participates in a variety of comittees</li><li>Foster a team environment</li></ul> •Conducts active, complex scientific research projects in collaboration with Pl and laboratory members. •Makes strong intellectual contributions to scientific strategies of the group/lab and plays a leadership role by acting as subject matter expert in field •Subject matter expertise in allergy/immunology research •Presents results and prepares data for publication •Reports on work in progress at weekly meetings and ad hoc seminar •Contributes to scientific literature and may present results at institutional and external academic meeting •Attends annual national scientific meeting as needed •Participation in grant proposal preparation •Administrative maintenance of database records and IRB document <ul><li>Lead additional special project oversight as requested</li></ul> Clinical Research Management Develop and maintain the infrastructure of a multicenter clinical trial by supporting the design, planning, and management activities, including the following: Regulatory •Submit IRB Applications and required reporting •Manage site regulatory documents and Trial Master File (TMF) •Manage ClinicalTrials.gov posting •Act as Principle Investigator for Coordinating Center submissions Study documents •Assist in preparation of protocol and informed consent form •Assist with recruitment material •Oversee preparation and maintenance of Manuals of Procedure •Oversee site and staff training material •Manage study portal and access to study documents and trial material Data management •Assist in developing Case Report Form •Assist in development study conduct report •Distribute report Safety and Monitoring (as applicable) •Develop Safety Monitoring plan •Review safety data •Report SAE/SUSARS to IRB •Develop site initiation and monitoring plan •Oversee interim monitoring •Conduct site close-out Site activation, training, and trial conduct •Site feasibility assessment development and implementation •Approve site activation •Provide site training and initiation •Investigation/remediation of site non-compliance Study closure and analysis •Site closure and reporting •Monitor return / destruction of unused IP (if applicable) •Notification of study closure to IRB •Prepare and submit Final Study Report •Archival of site records including site TMF •Oversee publication of study finding Administrative •Maintaining a list of all participating investigators, their research teams, legal contract teams and administrative teams. •Organizing regular meetings of the tr trial members, setting up agenda ahead of the meeting, recording minutes at each meeting and taking key notes from each meeting including voting and consensus and following up on all discussions. Record action items and ensure execution and follow-through. •Updating clinicaltrials.gov and other websites monthly and as needed •Schedule and organize Retreat/Symposium as needed. •Assist in development written materials for internal and external audiences in alignment with program and trial goal Quality and Process Improvement •Oversees development, implementation and administration of quality assurance plan This includes continuous development of metrics and tools to monitor, trend, and report performance measure •Facilitates and/or participates in communication with internal and external staff as it relates to training, performance measures, and quality assurance Personnel Management •Recruits and retains staff that reflects and support the mission •Builds and trains a team of clinical research professionals to support trial and CC conduct •Creates an environment of mentorship and career development Quality and Process Improvement •Oversees development, implementation and administration of quality assurance. This includes continuous development of metrics and tools to monitor, trend, and report performance measures. •Facilitates and/or participates in communication with internal and external staff as it relates to training, performance measures, and quality assurance. Qualifications <ul><li>PhD Required in Translational Medicine or Regulatory Affairs </li><li>Demonstrated evidence of scientific competency with highly specialized and developed skills, publications and/or experience </li><li>At least 3 years of clinical research experience</li><li>Ideally, minimum of 2 years working within an academic clinical trial coordinating center or regulatory management</li><li>High proficiency with Microsoft Office, particularly with Excel</li></ul> Skills/Abilities/Competencies Required: •Outstanding organizational skills are necessary to manage detailed information and priorities across competing timetables and responsibilities. Ability to plan for the timely and successful completion of short- and long-term objectives. •Excellent verbal and written communication skills to communicate effectively with a large and diverse constituency, including senior hospital leaders, division faculty and support staff, representatives of other BWH offices, collaborating institution officials, granting agencies (NIH, industry and foundations) representatives, and vendors. •Requires the ability to work independently to ensure protocol review, implementation and ancillaries processes run smoothly. •High degree of analytic ability to manage the financial and human resources aspects of the position. •Interpersonal relationship skills needed to collaborate with others and work with functional group managers, many hospital-wide department heads, administrators, and physicians in a positive and collegial fashion. •Comfortable using systems to create, update, maintain and disseminate data and reports. <ul><li>Demonstrated project and program management skills; ability to prioritize initiatives and ensure timely execution and follow through</li><li>Proven ability to balance "big picture" strategic planning with specific and detail focused deliverables</li><li>Skilled and knowledgeable liaison between high level academics, industry, and philanthropic partners</li><li>Demonstrated time management and organization skills</li><li>Knowledge of current and developing pre-clinical and clinical research trends</li><li>Sound interpersonal skills </li><li>Works well independently and in groups; displaying initiative and diplomacy while maintaining important work relationships</li><li>Demonstrated ability to successfully manage multiple projects </li></ul> •Highly skilled with demonstrated broad knowledge of field. •Evidence of potential for scientific creativity, original thought •Able to exercise independent judgment and leadership •Effective decision making in appropriate situation EEO Statement BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

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