Provide support to clinical research projects by assisting the Principal Investigator in data collection, survey implementation, and study-related clinical and administrative tasks for clinical research projects. Work effectively with patients, especially during the consenting process, and ensure all subjects meet study criteria. May participate in operating room data collection. Communicate study requirements and details in a clear manner to patients, families, and staff. Accurately update forms, data and study materials and maintain patient and study files.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Complete various tasks to assist the investigator in obtaining and managing data, including collect, organize and maintain patient data from medical records, physicians and other sources. Prepare data for analysis and data entry. Accurately input and use data. Assist the investigator with formal data audits. May participate in the creation of questionnaires and other study forms.
Utilize software programs to generate graphs and reports; provide data and information to investigator and may assist with interpretation and analysis.
Verify the accuracy of information submitted on study forms; investigate and resolve discrepancies. Update study forms per protocol.
Maintain all study, patient and administrative records, files and databases in an organized and accessible manner.
Conduct library searches for information related to the clinical research and trials.
Assist investigator in supporting study requirements by updating study forms per protocol, maintaining and updating regulatory binders and providing information for and assistance with submissions to study regulators.
Write consent forms.
Ensure all study and administrative tasks are performed in a timely and quality manner.
Provide feedback to the investigator and may make recommendations regarding study protocols.
Recruit patients for clinical trials by identifying potential subjects who may meet trial protocols, conducting screening of patients and verifying subject inclusion/exclusion criteria.
Work directly with patients to effectively communicate a basic explanation of the study protocol and related information and serve as an informational resource for patients and their families.
Conduct components of the study to include subject interviews and administration and scoring of questionnaires. May obtain informed consent. Create and maintain patient results and provide data to investigator. May perform procedures such as phlebotomy. May be present in the operating room for surgery-related studies.
Document patient visits and procedures in electronic and paper systems.
Trains and supervises new Research Assistants
Acts as a point of contact in communicating with the PI and outside site Investigators
Perform other duties as assigned
SKILLS & COMPETENCIES REQUIRED:
Working knowledge of clinical research protocols
Ability to demonstrate respect and professionalism for subjects' rights and individual needs
Computer literacy and working knowledge of data management program
Ability to interpret acceptability of data results
Able to learn and apply clinical skills such as phlebotomy
Ability to work independently and as a team player
Analytical skills and ability to resolve technical problems
Careful attention to details
Good organizational skills
Ability to follow directions
Good communication skills
Qualifications
EDUCATION:
Bachelor's degree required.
EXPERIENCE:
Preferred: Some relevant course/project work.
WORKING CONDITIONS:
Normal office conditions as well as sitting and computer use. Walking to patient rooms and operating rooms. Observation of study equipment functionality in operating room setting.
EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
