Clinical Rsch. Coord., Sr.
Company: Massachusetts General Hospital
Posted on: June 12, 2021
GENERAL SUMMARY/ OVERVIEW STATEMENT: Summarize the nature and
level of work performed.
Under the general supervision of the Cystic Fibrosis Center
Director and the Clinical Research Program Manager, the Senior
Clinical Research Coordinator has responsibility for oversight of
all research activities associated with projects related to Cystic
Fibrosis clinical research. The Senior CRC will operate with a high
degree of independence. Will assist in the development, submission,
coordination, and implementation of studies and projects related to
cystic fibrosis. Additionally, the Senior CRC will represent CF
Research at weekly Cystic Fibrosis team meetings, annual TDN
meetings, investigator meetings, and additional training seminars
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
Responsibilities include, but are not limited to:
- Works independently to manage projects with appropriate
guidance from the Principal Investigators and Program Manager.
- Works with the Principal Investigators to develop new research
- Manages all aspects of study documentation including regulatory
elements and IRB submissions.
- Develops and implements QA/QC practices.
- Works with the Grants Manager, Budget Analyst, and Principal
Investigators to coordinate different aspects of grants submission;
helps develop budgets and budget justification.
- Identifies and facilitates sub-contracting with third
- Oversees subject payments and reimbursements, and
- Assists Grants Manager and CF Center Directors with the
validation and reconciliation of study budgets.
Study and Project related activities:
- Acts as a liaison between sponsor, vendors, and internal
hospital departments (ex: TCRC, IRB) to initiate study
- Coordinates the ongoing training of study staff, including
facilitating Site Initiation Visits from sponsors, and regular
follow up with the study team.
- Assists Program Manager in coordinating the weekly Therapeutics
Development Network meeting.
- Manages and maintains the weekly research coordinator schedules
of study subject visits and Interim Monitoring Visits as
- Evaluates the eligibility of the MGH cystic fibrosis patient
population for participation in upcoming studies and works with the
study team to recruit study subjects.
- Represents the research team at Investigator Meetings and
national CF conferences.
- Corresponds with IRB & sponsor for approval, annual review, and
amendment of study protocols using Insight.
- Composes and amends consent forms, protocol summaries, and
other forms for sponsor & IRB review.
- Verifies subject inclusion/exclusion criteria during
- Schedules subjects and provides subject education (inform
subjects of compliance with protocol, identifies obstacles to
- Maintains subject records and logs of all study visits.
Data and Monitoring:
- Responsible for data control, including verifying accuracy of
study source documents and of study data entry, formal audits of
data, and maintaining study codes and regulations.
Performs other responsibilities and projects as required.
QUALIFICATIONS: (MUST be realistic, neither overstated nor
understated, and related to the essential functions of the
- BA/BS required within a scientific discipline
- Minimum of 3-5 years of related experience required
- International Council on Harmonisation Good Clinical Practice
(ICH-GCP) training preferred
- Human Subjects Protection Training (such as CITI)
- IATA Shipping of Dangerous Goods Certification preferred
- Additional clinical research professional licensing (SOCRA,
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: (MUST be realistic,
measurable, objective, and related to the essential functions of
- Ability to perform key study procedures including phlebotomy,
EKG, spirometry, sweat chloride tests, and vital signs measurement
(experience preferred, but training can be provided).
- Excellent verbal and written communication skills
- Sound interpersonal skills and the ability to supervise
- Demonstrates respect for and professionalism toward subjects,
their rights and individual needs.
- Ability to work independently and display initiative
- Ability to design, prepare, deliver, and evaluate clinical
- High level time management and organizational skills
- Ability to prepare and monitor budgets
- Ability to identify problems and develop solutions
- Ability to prioritize tasks and set deadlines
- Knowledge of clinical research protocols, hospital policies,
and FDA guidelines
WORKING CONDITIONS: Describe the conditions in which the work is
Work is performed primarily at the Cystic Fibrosis Clinical
Research Office, as well as at the Pediatric and Adult Cystic
Fibrosis Clinics. Some travel - about 10 days per year - is
SUPERVISORY RESPONSIBILITY: List the number of FTEs
- Assists with the protocol training of staff new to study
- Assists with the orientation of new staff
FISCAL RESPONSIBILITY: Indicate financial "scope" information,
i.e.: size of budget, volume, revnue, etc.
Tracking of all research-related funds, creation of study
budgets, and perform all office billing and invoicing.
Keywords: Massachusetts General Hospital, Boston , Clinical Rsch. Coord., Sr., Other , Boston, Massachusetts
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