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Clinical Rsch. Coord., Sr.

Company: Massachusetts General Hospital
Location: Boston
Posted on: June 12, 2021

Job Description:

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 as required.

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.

Responsibilities include, but are not limited to:

Research Development

  • Works independently to manage projects with appropriate guidance from the Principal Investigators and Program Manager.
  • Works with the Principal Investigators to develop new research protocols.
  • Manages all aspects of study documentation including regulatory elements and IRB submissions.
  • Develops and implements QA/QC practices.

Budgetary activities:

  • 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 parties.
  • Oversees subject payments and reimbursements, and invoicing.
  • 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 startups.
  • 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 needed.
  • 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 enrollment.
  • Schedules subjects and provides subject education (inform subjects of compliance with protocol, identifies obstacles to compliance).
  • 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 job.)

  • 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) preferred
  • IATA Shipping of Dangerous Goods Certification preferred
  • Additional clinical research professional licensing (SOCRA, ACRP) preferred

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED: (MUST be realistic, measurable, objective, and related to the essential functions of the job.)

  • 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 others
  • 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 research programs
  • 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 performed.

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 required.

SUPERVISORY RESPONSIBILITY: List the number of FTEs supervised.

None

  • 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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