Clinical Research Coordinator I - (3086088)
Description
GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and level of work performed.
The Massachusetts General Hospital Division of Cardiology is seeking a highly motivated individual for a Clinical Research Coordinator (CRC) I position to assist with ongoing and future clinical research studies for Dr. Farouc Jaffer in the CTO PCI and Complex PCI Programs.
The CRC I must be able to multi-task in a dynamic clinical research setting. The ability to work well in a team is a must. This is the ideal position for someone looking to work with a dedicated group of people to make new and enhanced medical device technology available to patients with complex coronary artery disease. The CRC I will gain invaluable experience in the field of cardiology in an academic clinical research setting and will have exposure to clinical procedures in the cardiac cath lab.
This is a full-time (40 hours/week) position; early morning (6:30-8am) and evening (5-8pm) hours are occasionally required to facilitate the conduct of the study.
This position is ideal for someone interested in pursuing graduate studies or a career in the fields of medicine, public health, or clinical research. It involves extensive work reviewing medical records to determine eligibility for multiple cardiology device trials as well as liaising with physicians across the institution to enroll patients in clinical trials.
PRINCIPAL DUTIES AND RESPONSIBILITIES: Indicate key areas of responsibility, major job duties, special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.
The Clinical Research Coordinator I has the following duties and responsibilities:
- Works with clinicians to screen subjects for suitability of research study participation
- Communicates with physicians throughout the hospital to coordinate enrollment of patients in clinical trials
- Maintains research data, patient files, regulatory binders, and study databases per FDA standards
- Acts as liaison between Sponsor, Sponsor Representatives, and PI
- May develop systems for QA/QC
- Organizes and interprets data
- Documenting before, during, and after cardiac procedures, clinics, or outpatient visits
- Develops and implements recruitment strategies
- Acts as study resource for patient and family
- May monitor and evaluate lab and procedure data
- Responsible for the administration and oversight of all study questionnaires
- Acts as liaison between Research Affairs and Unit
- Submits all Institutional Review Board (IRB) documentation
- Prepares documents and study binders for FDA audits (if needed)
- Recommends protocol changes and may assist with writing protocols and manuscripts
- Works with PI to prepare complete study reports, data management/statistical analyses, and presentations
- Monitors and manages study funds; prepares invoices; identifies and verifies patient care charges as appropriate
- Orients and trains junior team members on the study protocols as appropriate
- Assists in the coverage of other research studies when necessary
Qualifications
SKILLS/ABILITIES/COMPETENCIES REQUIRED: Must be realistic, objective, measurable and related to essential functions of this job.
The Clinical Research Coordinator I should have the following skills and competencies:
- Excellent written and oral communication skills
- High degree of computer literacy including Microsoft Excel and Word programs
- Ability to work independently and as a team member
- Analytical skills and ability to resolve technical problems
- Ability to multi-task and prioritize responsibilities
LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable): Specify minimum credentials and clearly indicate if preferred or required
Training in CITI and GCP preferred.
EDUCATION: Specify minimum education and clearly indicate if preferred or required
Minimum education required BA/BS (preferred in science related field).
EXPERIENCE: Specify minimum creditable years of experience and clearly indicate if preferred or required
None.
SUPERVISORY RESPONSIBILITY (if applicable): List the number of FTEs supervised.
None.
FISCAL RESPONSIBILITY (if applicable): Indicate financial “scope” information, i.e.: size of budget, volume, revenue, etc.; Indicate total physician/non-physician FTE scope
Monitor and manage study funds. Responsible for preparing and tracking invoices and for directing, verifying, and correcting patient care charges as appropriate.
WORKING CONDITIONS: Describe the conditions in which the work is performed.
Duties will be performed in an office and hospital setting in the Cardiac Cath lab, inpatient units, and outpatient clinic.
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. Primary Location
: MA-Boston-MGH Main CampusWork Locations
:
MGH Main Campus
55 Fruit Street
Boston 02114
Job
: ClinicalOrganization
: Massachusetts General Hospital(MGH)Schedule
: Full-time
Standard Hours: 40
Shift
: Day JobEmployee Status
: Regular
Recruiting Department: MGH Cardiovascular Research Center