CLINICAL RESEARCH COORD. II
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POST DATE 8/16/2016
END DATE 11/1/2016
Massachusetts General Hospital(MGH)
JOB DESCRIPTIONAPPLY GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Massachusetts General Hospital Division of Cardiology is seeking a highly motivated and experienced individual for a Clinical Research Coordinator (CRC) II position to assist with ongoing and future clinical research studies for a multidisciplinary team of providers in the Heart Valve Program.
The CRC II 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 an array of cardiac conditions. The CRC II will gain invaluable experience in the field of Cardiology in an academic clinical research setting.
This is a full-time (40 hours/week) position, evening hours and weekend hours may occasionally be 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:
The Clinical Research Coordinator II 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
* Submit all Institutional Review Board (IRB) documentation
* Prepare 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 preparing presentations
* Monitors and manage study funds, prepares invoices, identifies and verify 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
The Clinical Research Coordinator II 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:
Training in CITI and GCP preferred.
Minimum education required BA/BS (preferred in science related field).
Minimum of 1 - 2 years clinical research experience.
Orients and trains new staff. May oversee staff in lower-level positions.
May monitor and manage study funds. Responsible for preparing invoices and for directing, verifying, and correcting patient care charges as appropriate.
Duties will be performed in an office and hospital setting in the Electrophysiology lab and clinic area.
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.