The Research Specialist II will oversee and manage multifaceted clinical aspects of the research studies performed in the Seidman laboratory. This role involves coordinating patient recruitment, obtaining clinical samples and data, and ensuring compliance with institutional and federal regulations. The Research Specialist II will also collaborate closely with healthcare providers, research teams, and patients, contributing to the overall success of translational and clinical research within the lab.
Key Responsibilities:
Study Design and Coordination:
- Participates in experiment design, collecting samples, and monitoring experiments.
- Provide support with publishing reports such as preparing findings for publication and assisting in laboratory analysis, quality control, or data management; may present at conferences.
- Support development of additional research dissemination materials such as presentations for internal, partner, funder, and external audiences.
- Collaborate with physicians, researchers, and trainees involved in studies.
- Monitor and report any adverse events or deviations from study protocols.
- Assist in the preparation of manuscripts, presentations, and grant proposals.
- Lead writing and submission of peer-reviewed research manuscripts.
Patient Recruitment and Enrollment:
- Identify, recruit, and screen eligible patients for genomic and transcriptomic studies.
- Obtain informed consent from study participants.
- Maintain detailed records of participant recruitment and data collection.
Sample/Data Collection and Clinical Coordination:
- Organize and manage clinical study logistics, including appointment scheduling.
- Obtain vital signs, EKG, and venous blood, saliva sample, and/or tissue from consented subjects.
- Process samples for storage for subsequent experiments.
- Ensure proper administration and documentation of clinical study protocols.
- Serve as a primary point of contact for study participants, answering questions and providing support throughout the study.
- Develop detailed concept notes, IRB documents, research proposals, and study protocols.
- Lead development of data collection tools.
- Conduct literature reviews, including scoping reviews, using prior training in epidemiology, considering issues of study design, analysis, and sources of error (random error, bias, and confounding).
- Lead online creation, implementation, and management of multi-country surveys using REDCap or Qualtrics.
- Assess data submitted by site partners for completeness and quality, troubleshooting with partners as needed.
- Lead preparation of IRBs including creating submission materials and supporting international partner sites with local IRB submissions.
- Conduct data analysis and reporting of preliminary findings independently or collaboratively as appropriate under supervision of the Director of Research.
Data Collection and Management:
- Collect and manage patient data in compliance with study protocols.
- Manage and inventory stored data and samples, ensuring accuracy and security.
- Collaborate with research teams to ensure timely and accurate reporting.
Regulatory Compliance:
- Ensure compliance with all institutional, state, and federal regulatory requirements for clinical research.
- Prepare and submit necessary documentation to the Institutional Review Board (IRB).
- Maintain up-to-date certifications and training required for clinical research.
Other:
- May supervise junior staff, including technicians.
- Collaborate with research partners at international sites in data collection and research activities.
Qualifications:
- Clinical degree strongly preferred (i.e. BSN, PA, NP).
- Experience in the field of human cardiovascular genetics strongly preferred.
- 5-7 years of experience in clinical research with expertise in obtaining vital signs, venous blood samples, electrocardiograms.
- Strong knowledge of IRB procedures, FDA regulations, and clinical trial protocols.
- Excellent communication and organizational skills.
- Ability to work collaboratively in a multidisciplinary team.
- Proficiency in medical terminology, electronic medical records (EPIC) systems, and clinical data management software.
- Demonstrated commitment to diversity, inclusion, and cultural awareness through actions, interactions, and communications with others.
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
Job
Research - Other
Organization
Brigham & Women's Hospital (BWH)
Schedule
Full-time
Standard Hours 40
Shift
Day Job
Employee Status
Regular
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