Clinical Research Coordinator II

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The selected candidate will work with our existing research team to coordinate clinical research projects under the direct supervision of the principal investigators. The candidate will be primarily responsible for running a single center, randomized controlled trial with a focus on patients with Exocrine Pancreatic Insufficiency in the setting of Acute Pancreatitis. The candidate will work with members of our multidisciplinary pancreatitis team including gastroenterologist, surgeons, and registered dieticians. The Coordinator will obtain informed consent once study patients have been identified and educated about the study.

The candidate will work full time (40 hours/week) however the schedule will require flexibility and may include occasional evenings depending on time-management and patient schedules. The research study will continue for approximately 2.5 years. This research environment is highly conducive to individuals interested in eventually pursing medical, graduate, or public health advanced degrees.

Collaborates with supervisor to create and maintain a database of clinical protocol data. The Coordinator will be a resource for teaching other personnel about the study and associated database. Carries out a wide range of moderate to complex data management functions with a full understanding of the principles underlying the choice and use of statistical tests; responsible for creation of graphics/slides for manuscripts and oral presentations. Collaborates with supervisor in writing and editing material for publication.

This position offers the opportunity to work directly with patients and physicians, and it will provide foundational skills in conducting clinical research in a large, academic medical center. In addition to the main clinical trial, there will be additional research opportunities, as well as opportunities for research presentation and publication if the individual is interested.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Recruitment/Enrollment - In conjunction with Clinical Research RN and various physician investigators in the Division of Transplant, develops and implements study recruitment strategies and procedures:

• Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports and other documents
• Recruit and enroll eligible study participants from the inpatient hospital wards
• Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion
• Perform all patient related interviews in both the inpatient and outpatient settings
• Provide teaching and monitoring for research participant diaries
• Capture clinical information from record review and patient interview into study database
• Perform bio-specimen processing, as indicated
• Manage and maintain regulatory documents for audit by FDA, as needed
• Act as primary study resource for laboratory staff, patients and families
• Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator
• Conduct regular review of study progress and follow-up
• Performs administrative support duties as required
• Attend weekly coordinator meetings, and prepare weekly reports of work performed

2. Regulatory Compliance - With supervision from the PI and/or Research Team, develops and maintains protocol specific documents, IRB amendments and reviews, and regulatory report submissions. Duties include:

• Verifies accuracy and updates study forms;
• Assists with study regulatory submissions, including preparing and submitting regulatory documents to study data repositories
• Maintains regulatory binders for trials in the Division of Transplant
• Contributes to protocol recommendations and communicates these with Clinical Research Manager, RN;
• Prepares protocols for review by the required hospital subcommittees: Pharmacy and/or IRB;
• Drafts amendments to protocols, based on requests and suggestions by the P.I., and submits these for IRB approval.
• Prepares annual renewal for the IRB Approval.

3. Data Management - Obtains and organizes patient data from medical records, physicians, etc., following HIPAA guidelines:

• Study data entry;
• Uses software programs to generate graphs and reports;
• Maintains research data, patient and study files
• Maintains study codes;
• Assists with formal audits of data
• Performs data analysis and QA/QC data checks
• Organizes and interprets data
• Monitors and evaluates lab and procedure data
• Administers/scores/evaluates study questionnaires

4. General Office & Laboratory Support:

• Oversees bio-tissue collection and sample processing, per study protocol
• Ships and stores specimens, as required by protocol.

5. Assumes additional administrative and clinical research tasks, as needed.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Extraordinary attention to detail, ability to work carefully and efficiently with limited supervision once appropriate training has been provided;
• High level of proficiency with Microsoft Excel, Word, PowerPoint and computer data entry skills required;
• Experience with medical chart reviews and electronic medical records (EPIC). Knowledge of database management strongly preferred;
• Ability to interpret acceptability of data results;
• Analytical skills and the ability to resolve technical problems.
• Good judgment and problem-solving skills, ability to juggle multiple tasks, people and schedules
• Ability to demonstrate professionalism, compassion and respect for study participants' rights and needs
• Excellent oral and written communication skills in English
• Ability to work both independently and as part of a busy, multidisciplinary team, interacting with diverse individuals at multiple levels within the research and clinical group
• Work hour flexibility. Some visits start early in the morning (7 am) and there may be intermittent work after normal business hours

QUALIFICATIONS:

• Bachelor's degree (required)
• 1 -2 years of Research related experience required

WORKING CONDITIONS:

• Office and clinical setting, 40 hours per week - Some flexibility in schedule
• A full study commitment is preferred (approximately 2.5 years), but not required

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.