Clinical Research Coordinator II

Mass General Brigham
Published
June 30, 2022
Location
United States
Category
Other  
Job Type
Work Setting
In-office

Description

The Massachusetts General Hospital Department of Emergency Medicine is seeking a highly motivated individual to assist with ongoing and future clinical research. Through participation in a variety of federally funded and industry-sponsored studies, we aim to find new and effective treatments for a range of emergency conditions.

The successful candidate will be highly motivated and eager to interact with patients with acute illness and their families in a fast-paced hospital setting. A high level of maturity is essential, as the coordinator is given access to personal and confidential medical information. Strong organizational and interpersonal skills, attention to detail, and the ability to prioritize multiple tasks are essential. Must demonstrate analytical skills, ability to resolve technical problems, ability to interpret acceptability of data results, and have a working knowledge of data management programs.

The candidate will support the missions of both the Center for Neurologic Emergencies and the Center for Vascular Emergencies. Receiving general direction from the PI(s) and according to established policies, procedures, and detailed instructions, the incumbent will support a range of research and educational activities. This work will include:

  • Launching, conducting, and closing out clinical trials, registries, and observational studies
  • Data abstraction and management
  • Communication with the IRB, across departments, hospitals, and study sponsors.

The candidate will approach, screen, consent, and enroll patients in a range of studies. In addition, they may help support both educational and quality initiatives undertaken by the two Centers.

This is a full-time (40 hours/week) position. Evening hours and weekend hours will be required. The candidate may need to be on-call during weeknights or weekends. The ability of the successful candidate to take calls is preferred.

Principal Duties and Responsibilities:

The role of the Clinical Research Coordinator is to support the efforts of the Centers for Neurologic and Vascular Emergencies. Major duties include but are not limited to:

Subject Enrollment

  • Develops and implements recruitment strategies
  • Assists with screening, informed consent, and enrollment of patients
  • Recruits patients for clinical trials and observational studies
  • Independently judges suitability of research subjects
  • Effectively communicates information about a study to patients and families
  • Acts as a study resource for patients, family, and clinical and research staff
  • Verifies subject inclusion/exclusion criteria
  • Obtains informed consent from subjects
  • Interviews subjects
  • Administers, scores, and evaluates questionnaires
  • Performs study procedures such as phlebotomy, specimen processing, and storage, etc
  • Coordinates lab activities
  • Documents patient visits and procedures
  • Obtains patient data from medical records, physicians, etc
  • Collects and organizes patient data
  • Verifies accuracy of study forms
  • Maintains study codes

Regulatory

  • Responsible for all IRB and regulatory submissions
  • Ensures that annual IRB applications are submitted in a timely fashion
  • Writes consent forms
  • Identifies and reports minor and major protocol deviations to appropriate agencies
  • Files adverse events with the IRB and study sponsors
  • Updates study forms per protocol
  • Recommends protocol changes and may assist with writing protocols
  • Designs research protocols in conjunction with PI
  • Maintains research data, patient files, regulatory binders, and study databases
  • Performs and is responsible for QA/QC procedures and checks
  • Takes responsibility for quality control
  • Writes SOPs (Standard Operating Procedures)
  • May develop systems for QA/QC
  • Maintains records and databases
  • Prepares data for analysis and data entry
  • Assists with data analysis and formal audits of data
  • Uses software programs to generate graphs and reports

Data Analysis

  • Organizes and interprets data
  • Plans, designs, and performs statistical analyses
  • Monitors and evaluates lab and procedure data
  • Prepares study reports

Financial

Develops study budgets

  • Creates tracking tools to ensure studies and research programs remain on budget
  • Participates in meetings May assume grant management responsibilities for a research program

Other

  • Conducts library searches
  • Creates posters for annual conferences
  • Assists with data analysis and manuscript writing
  • Provides grammar and copyediting review/support for reports and manuscripts
  • Performs other study-related or administrative duties as needed or requested

Skills & Competencies Required

  • Excellent interpersonal and management skills with the facility to interact professionally at all levels and plan and initiate new activities.
  • 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 is required for patient interviews and chart reviews.
  • Knowledge and experience with human subject research and IRB requirements.
  • Administrative skills to meet the regulatory compliance required by IRB reporting.
  • Excellent written and verbal communication skills.
  • High-level time management skills require 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.
  • Experience with common software including Microsoft Office, REDCap, and reference management software such as Reference Manager or EndNote is preferred.
  • Facility with learning new computer applications.
  • Ability to conduct reference and literature searches using PubMed and other search engines and perform Internet searches using various search engines.
  • Good typing and proofreading skills.
  • Ability and willingness to learn new research and administrative skills.
  • Ability to compile and manage data, analyze information, and produce reports.
  • Assist with materials management, supply, inventory, and ordering of program materials.
  • Knowledge of current and developing trends in areas of professional expertise.

Supervisory Responsibility

  • Will participate in the training, orientation, and education of research staff, interns, and volunteers.
  • Assesses research staff and interns’ competency.
  • Trains junior research staff (including but not limited to CRC staff, RAs, BFTs, MGH non-employees, interns, and volunteers)

Fiscal Responsibility

  • Responsible for managing research projects and program supplies within budgetary guidelines.

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. You must be available by pager/cell phone outside of normal business hours. May be required to report to the hospital outside of normal business hours to assist with events that require emergency management

Experience

  • At least 2 years of clinical research experience as related to the duties and responsibilities specified are strongly preferred. 1 year of related research experience is required.
  • Experience with IRB administration and data management.

Preferred

  • Prior Supervisory experience
  • Phlebotomy

Education

Required: Bachelor’s Degree

Preferred: Master’s Degree

Certifications

Required: CITI (can obtain during the first week)

Preferred: GCP

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