GENERAL SUMMARY/ OVERVIEW STATEMENT:

Under the general supervision of the Senior Clinical Research Program Manager (SCRPM) and the Director of the Center for Vascular Emergencies (CVE), the Clinical Research Coordinator (CRC) provides support for CVE research projects in the Department of Emergency Medicine. The CVE was created to improve the care of patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) through multidisciplinary research, clinical innovation, and education. The incumbent will be a highly integrated team member interfacing with Investigators, Fellows, Residents, research interns, and departmental research staff on a regular basis.

PRINCIPAL DUTIES AND RESPONSIBILITIES: The CRC will work on a variety of projects to support the CVE. The CRC reports jointly to the SCRPM and the Director of the CVE.

Subject Screening / Enrollment:

• Develops and implements recruitment strategies
• Assists with screening, informed consent, and enrollment of patients
• Verifies subject inclusion/exclusion criteria
• Obtains informed consent from subjects
• Conducts subject interviews
• Performs study procedures such as phlebotomy, EKGs, vital signs, sample processing, etc
• Documents patient visits and procedures and obtains patient study data from medical records, clinicians
• Acts as a study resource for patients, families, and staff
• Collects, organizes and enters data as required by protocols
• Verifies accuracy of study forms
• Maintains study codes
• Completes and maintains study screening logs, source documentation, and case report forms
• Actively participates in meetings and teleconferences with other research colleagues
• Organizes and presents study screening and enrollment results, sharing best practices, and troubleshoots challenges
• Schedules and performs study follow-up visits

Institutional Review Board (IRB) and Regulatory:

• May assist with writing and altering protocols, informed consents and other study documents.
• May draft and submit applications to the IRB, including initial submissions, amendments, and continuing reviews
• Meets regularly with study PIs to review subject and study data and assists with the monitoring for and reporting of adverse events and protocol deviations.
• Creates standard operating procedures to standardize study activities at the site
• Prepares and maintains regulatory binder
• Performs QA/QC procedures
• Collects and prepares data for monitoring, audits, and analysis
• Participates in formal monitoring visits and audits of data
• Prepares data for analysis and data entry
• Uses software programs to create graphs and reports

Other:

• Maintains inventory, stocks and orders supplies
• Calibrates or updates study equipment
• May assist with drafting grant applications
• Conducts library searches
• Creates posters, abstracts, and presentations for annual conferences
• Provides grammar and copyediting review/support for reports and manuscripts
• May help train/orient new staff
• Performs other study related or administrative duties as needed or requested

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• High level time management skills requiring exceptional organizational skills and the ability to organize time and prioritize effectively. This includes the ability to ask for direction when appropriate and the flexibility to handle multiple tasks and deadline pressures.
• Excellent written and verbal communication skills.
• Excellent judgment and ability to interpret information and protocol requirements.
• Excellent organizational skills to formulate and complete vigorous timelines to meet grant deadlines.
• Excellent interpersonal skills with facility to interact professionally at all levels as well as be a part of an integrated research team.
• Ability to design, prepare, deliver, and evaluate SOPs, source documents, and other documents.
• Ability to compile and manage data, analyze information, and produce reports.
• Clinical knowledge as required for patient interviews and chart reviews.
• Knowledge and experience with human subjects research and IRB requirements.
• Administrative skills to meet regulatory compliance requirements.
• Experience with common PC computer software including Microsoft Word, PowerPoint, Excel, Access and Outlook, and reference management software such as Reference Manager or EndNote.
• Facility with learning new computer applications.
• Assist with materials management, supply, inventory, and ordering of program materials.
• Knowledge of current and developing trends in areas of professional expertise.
• Ability to conduct reference and literature searches using PubMed and other search engines and perform Internet searches using MS Internet Explorer and various search engines.
• Typing speed of 50+ wpm.
• Good proofreading skills.
• Ability and willingness to learn new research and administrative skills.

EDUCATION: 

• Bachelor's degree required.

EXPERIENCE: 

• New graduates with some relevant course / project work or those without any prior research experience will be considered for the position outlined above.

• Preferred: Experience with IRB administration and data management.
  

Working Conditions:

Works in an office setting and in the clinical environment of the Emergency Department. May be required to attend and travel to meetings outside of regularly scheduled hours. May be required to report to the hospital outside of normal business hours to assist with events that require emergency management.

Posted Shift Description: Candidates should expect to work a rotating shift of weekday and weekend hours. The daytime shifts will be 7am-3:30pm (or 8am-4:30pm) and the evening shifts will be 2:30-11pm.

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.