Clinical Research Coordinator II at Massachusetts General Hospital(MGH)

Posted in Other 8 days ago.

Location: Boston, Massachusetts





Job 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 and experienced individual for a Clinical Research Coordinator (CRC) II position to assist with ongoing and future clinical research studies.


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 treatments 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.The CRC II will be working with two investigators who lead trials investigating various aspects of cardiovascular disease in women. Ongoing trials include a national registry of women with spontaneous coronary artery dissection. Another trial involves entering data into an established international registry of pregnant women with cardiovascular disease.


This is a full-time (40 hours/week) position; evening and weekend hours are rare, but may 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 research. It involves extensive patient interaction as a member of a clinical research team. Administrative responsibilities are also required of the individual who fills this role.


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 II has the following duties and responsibilities:

  • Collates and files forms, documents and other paperwork to set up and maintain research data (paper and electronic), patient files and regulatory binders per FDA, IRB and sponsor standards

  • Updates databases with data on patients in the study; ensures accuracy of data; may prepare charts and graphs; print reports and ad hoc data request

  • Presents and interprets data and QA reports during meetings and for study leaders

  • Acts as liaison between Sponsor and research team to communicate changes in study protocols, provide information on events and share program updates

  • Works with physicians and nurses to screen subjects for research study by reviewing patient data for eligibility; ensures patients referred meet study criteria

  • Coordinates patient recruitment to source and enroll patients referred to studies; ensures patients meet protocol requirements

  • Performs database searches and medical record searches using tools such as the electronic data warehouse (EDW) or the Research Patient Data Registry (RPDR). Experience with computer programming (python) or database management is a plus but not required.

  • Administers and coordinates all study questionnaires presented to study patients; reviews questionnaires for completion, files questionnaires and performs related data entry

  • May be required to take call on nights, weekends, and holidays dependent on research study parameters

  • Obtains informed consent from potential study patients when appropriate

  • Acts as liaison between IRB and research team by submitting and maintaining IRB documents, such as protocol amendments and annual reviews; communicates study information and updates; may coordinate IRB related activities with study sponsor to include forwarding of study materials

  • Presents study binders for FDA and sponsor audits as well as monitoring visits by sponsor, as needed

  • Notifies research team regarding protocol performance and possible protocol changes; may work with the team to update/edit protocols

  • Gathers and provides data to team; collaborates with team members to analyze data, prepare abstracts, manuscripts/publications and presentations

  • Utilizes Epic to identify and verify patient care charges as appropriate to study funds and/or insurance

  • Performs as a team member on other research studies within Cardiology when requested

  • Attends and participates in research team staff meetings

  • Maintains and orders lab and office supplies

  • Appropriately utilizes lab and patient care equipment and supplies

  • Enthusiastically performs other duties as needed





  • Qualifications

    SKILLS/ABILITIES/COMPETENCIES REQUIRED: Must be realistic, objective, measurable and related to essential functions of this job.


    The Clinical Research Coordinator II should have the following skills and competencies:

  • High degree of computer literacy including Microsoft Excel and Word programs.

  • Experience with computer programming (python) or database management is a plus but not required.

  • Ability to work independently and as a team member.

  • Analytical skills and ability to resolve technical problems.

  • Ability to multi-task and prioritize responsibilities.

  • Highly effective communication skills (written and verbal) to provide instructions to patients, document procedures and create material for publication




  • LICENSES, CERTIFICATIONS, and/or REGISTRATIONS (if applicable): Specify minimum credentials and clearly indicate if preferred or required


    Training in CITI and GCP preferred. Certification is also available upon hire.


    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


    Minimum of 1 - 2 years Clinical Research experience including experience working on IRB submissions required. Statistics proficiency preferred.


    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


    May monitor and manage study funds. Responsible for preparing 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 including activities in outpatient, inpatient, and procedural units at Massachusetts General Hospital. May be exposed to blood products, sharp instruments such as needles, and cleaning supplies. Will require walking and occasionally lifting medium objects.



    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.
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