GENERAL SUMMARY:Interacts with patients prior to entering the study and throughout the entire cardiac treatment. Discusses and obtains informed consent with patients. Revises protocol consent form to comply with federal, state and IRB guidelines.Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Checks all eligibility or ineligibility criteria with the patients' medical record. Verifies information with clinical research nurse and/or Principal Investigator.Present for enrolled patients' cardiac catheterization laboratory procedures to collect data and advise investigators on research-related protocols/requirements.Organizes and maintains study databases. Responsible for data validation and quality control.Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB. Works in concert with Principal Investigators, nurses, technologists, PAs and sponsors. May prepare reports for sponsor monitors as well as routine audits for the FDA, if applicable.Participates in hiring and training additional/future Clinical Research Assistants. Ensures that schedules, follow up and completion of research protocols progress as planned. Works with staff to resolve day-to-day problems.Assists in the execution of new both internal and external IRB applications and processes annual reviews for the IRB committees with regard to consents. Working with the principal investigator to submit protocols, amendments, notices, suspensions and terminations to the IRB for review and approval.Assists PI or Research Manager with preparation for presentation and written published articles.Qualifications QUALIFICATIONS:Bachelor's degree required. Bachelor's degree in scientific discipline preferred.1-3 years related work experience required.Experience in a medical setting and/or in clinical research.Knowledge of data management programs preferred, including electronic data cap
The Cardiac Catheter Laboratory (CCL) is an exciting, fast-paced, and growing environment seeking an additional highly motivated, experienced Clinical Research Assistant to oversee daily operations of 10+ clinical trials within the Department of Cardiology. The nature of the job requires the ability to work very independently, be dynamic, and to multi-task with general supervision from 1-2 interventional cardiologist Principal Investigators (PIs). The clinical research assistant will work not only with the PIs, but also the department, sponsor, and institution to support guidance overseeing compliance, financial personnel, and other related aspects of clinical study. The ideal candidate would be for an individual seeking work within a dedicated team to interact with patients and support the advancement of new and enhanced medical device technology offered to patients with cardiac conditions. This position is full-time (40 hours/week) with possible evening hours.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Ability to make decisions that are guided by general instructions and practices requiring some interpretation. Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.Ability to follow precedents and procedures. Seeks assistance when confronted with difficult and/or unpredictable situations.Excellent organizational skills, careful attention to detail, and ability to prioritize a variety of tasks.Excellent interpersonal skills to communicate effectively with medical center staff, patients, families and sponsors.Ability to demonstrate full working knowledge of standard data management procedures, practices and policies with the ability to use them in varied situations.Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner.
Responsible for training and orienting new staff. May serve as a team leader or supervisor in a smaller research setting.
Work conditions include shared and private office spaces as well as the cardiac catheterization laboratory at the main hospital.
Will not be required to lift more than 20lbs.
ture systems.EEO Statement
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.