Research Assistant II 40 Hours Day Bwh - Cardiovascular Medicine
Research Assistant II 40 Hours Day Bwh - Cardiovascular Medicine
Posted on :
10-04-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
10-04-2025
Job Description
QUALIFICATIONS:
The ideal candidate will possess the following:
- Bachelor degree required masters preferred
- Two to three years of relevant experience in clinical research academic medical center or equivalent with a strong cardiovascular knowledge base preferred.
- Proficiency with PCs and windowsbased software including Word and Excel.
- Basic skills in the analysis of epidemiological data preferred.
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
The ideal candidate should have:
- Excellent interpersonal and strong organizational skills and be able to work independently as well as in the team settings.
- Comfort in an intensive care unit setting preferred
- Excellent interpersonal oral and written communication skills
- Ability to effectively solve problems balance multiple priorities and handle confidential issues
- Knowledge of federal and institutional policies governing clinical research
- An advanced working knowledge of clinical research requirements and expectations.
- Advanced computer skills including ability to manage data capture and database design.
- Capability for independent problemsolving organization and comanagement of clinical research operations.
- Excellent judgment and ability to interpret information and protocol requirements and initiate appropriate actions
- Outstanding written and oral communication skills to work with individuals from various fields of expertise and with participants from various backgrounds as well as function effectively as a member of a research team
- Careful attention to detail and strong documentation skills
- Excellent organizational abilities to complete tasks within aggressive deadlines and competing priorities
- MS Office Suite literacy required and experience with data management systems
GENERAL SUMMARY/OVERVIEW STATEMENT:
The Research Assistant will be involved in coordinating the clinical research activities and quality improvement data management and analysis for the Cardiac Intensive Care Unit (CICU) of the Cardiovascular Division at Brigham and Womens Hospital. The candidate must possess ability to work independently in all phases of clinical research. Must comply with hospital regulatory requirements NIH Guidelines and HIPAA regulations.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Responsibilities include supporting CICU investigators in all of the stages of clinical research: including research initiation regulatory (IRB) submission care coordination of patients required education of staff in pt. care maintenance and adherence of protocol protocol medications and procedures as well as protocol requirements monitoring of data reporting to both sponsor and IRB until closeout of each study. In addition the Coordinator will also devote substantial effort to managing data collection and analysis for selected quality improvement initiatives linked to the CICU. The Assistant will function in the comanagement of clinical research and CICU database activities with the CICU Director and investigators. Principal responsibilities include but are not limited to:
- Develops implements and maintain databases (REDCap StudyTrax) for several CICUbased projects
- Oversees the project database data management data collection and data quality. Reviews and analyzes data to ensure consistency integrity and accuracy based on project specific guidelines
- Responsible for creating data reports and presents regular and adhoc study progress reports for weekly meetings and study sponsors.
- Participates in regular meeting with QI and project teams
- Contributes to preparation of abstracts and manuscripts for publication.
- Actively responsible for the recruitment of study subjects. This includes developing and implementation of recruitment strategies telephone screening of potential subjects enlisting participation by scheduling appointments and sending out necessary paperwork.
- Performing study visits including administration of consent following procedures for study visits and appropriate follow up with subjects.
- Collects and reviews study data ensuring compliance with protocol and data integrity. Maintain case report forms regulatory binders perform followup contacts and maintain meticulous study records. Obtain and process biological samples according to protocol after completing any necessary training.
- Drafts corrective action plans for any issues identified through QC. Ensures queries are responded to in a timely manner.
- Oversees regulatory aspects of trials including monitoring or coordinating a monitoring body safety and protocol violation documentation as appropriate. Develops and prepares content for study IRB submissions amendments continuing reviews and reports. Ensures auditready files are kept.
- Serves as the primary contact for assigned projects for both internal and external communications. Directly responds to inquiries regarding study protocol and policy. Ensures necessary meetings are held and minutes kept and distributed. Hosts site visits. Negotiates study timelines and keeps team members accountable.
Employment Type
Full-Time
Key Skills
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