Under the general supervision of the Cystic Fibrosis Center Director and Research Program Manager, the CRC I will work with research study subjects, staff, sponsors, and third-party vendors to run clinical research studies. The CRC I also works professionally with clinic staff and internal hospital departments to ensure that hospital and clinic protocols are followed. The CRC I consistently strives to assure and improve the quality of all aspects of the Cystic Fibrosis Clinical Research program.
Cystic fibrosis (CF) is an inherited disorder affecting approximately 30,000 people in the United States. While classified as a rare disease, CF is one of the most common life-limiting inherited diseases in the US. The MGH CF Clinical Research Center is comprised of pulmonologists who treat adult cystic fibrosis patients, pediatric pulmonologists, clinical research coordinators, and a research manager. Our mission is to develop new therapies, improve current treatments, and explore new questions about CF pathophysiology. The research team is responsible for several clinical trials including observational patient registry studies, investigator-initiated quality improvement studies, and interventional drug trials. Of the CF patients seen at MGH, the research team works primarily with adults and adolescents, engaging patients and their families in research. The past 20 years have seen life expectancies for cystic fibrosis patients increase into their forties due to advances in care.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.
Completes required hospital, departmental, disease-specific, and study-specific training.
Works directly with subjects to execute assigned studies by:
Meeting or speaking with patients to assist in recruitment for clinical trials
Providing basic explanations of studies to patients and families,
Scheduling study visits and reminding participants of their upcoming visits,
Interviewing study participants to collect accurate study data
Collecting, processing, and shipping/transporting blood, urine, sweat, sputum, tissue and stool samples
Administering and scoring questionnaires
Performing and documenting study procedures such as vital signs collection, EKG, and spirometry, and presenting these to the PI group for review
May obtain informed consent from subjects for some simple studies, in accordance with hospital policy.
Assists with study regulatory submissions and maintenance by:
Providing regulatory documents to the sponsor
Providing information in budget reviews
Drafting in collaboration with the manager consent forms, protocol summaries, and other documents for sponsor and/or IRB review
Completing Insight e-IRB applications
Ensuring that study documents are stored, maintained, and routed in compliance with applicable federal, hospital, departmental, and study-specific regulations.
Maintaining study records including logs
Assists with Quality Assurance/Quality Control and auditing/monitoring procedures by:
Scheduling sponsor/third party monitoring visits
Assisting the monitor in data and protocol reviews, and appointments
Self- and peer-reviews documented procedures
Working with the study team to resolve data queries and ensure that data in electronic databases are accurate
Works directly with the PI group to execute assigned studies by:
Reviewing patient medical records to assist with identifying study candidates
Preparing safety reports and other study progress reports for PI review
Ensuring that PI group receives results of study tests and procedures
Participates at weekly Cystic Fibrosis team meetings, annual TDN meetings, investigator meetings, and additional training seminars as required.
SKILLS/ABILITIES/COMPETENCIES REQUIRED: Must be realistic, objective, measurable and related to essential functions of this job.
Careful attention to details
Good organizational skills
Ability to follow directions
Ability to take initiative when working independently and as an easily-engaged team member.
Good verbal & written communication skills and organization skills.
Preliminary knowledge of clinical research policy.
Preliminary knowledge of laboratory/processing procedures.
Computer literacy, including Office Outlook, Excel, and Word.
Ability to demonstrate respect for and professionalism toward subjects, their rights and individual needs.
Bachelor's degree required. BS/BA required, preferably in a scientific discipline.
Relevant course or project work with previous lab and/or clinical research preferred.
SUPERVISORY RESPONSIBILITY (if applicable): List the number of FTEs supervised.
FISCAL RESPONSIBILITY (if applicable): Indicate financial "scope" information, i.e.: size of budget, volume, revenue, etc.; Indicate total physician/non-physician FTE scope
Assists in the creation of study budgets and performs billing and invoicing for assigned studies, approximately $100,000 per annum.
WORKING CONDITIONS: Describe the conditions in which the work is performed.
This is not a laboratory position. Most of the CRC's time will be spent in the clinical research office, which adjoins the outpatient clinic at which study participants are seen.
Some overnight travel - approximately 10 days per year - is required.
Work entails approximately 20% walking/standing, and some light lifting.
Research manager and/or PI regularly reviews progress of work.
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.