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CLINICAL RESEARCH COORD. II

Massachusetts General Hospital(MGH)


Location:
Boston, Massachusetts
Date:
05/01/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Massachusetts General Hospital(MGH)
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  • Research Salary

Job Details

Scope of Position

 

The Clinical Research Coordinator is an integral member of an interdisciplinary team which supports the study of patients and normal volunteers within a clinical investigational setting focussing on critical research issues in Neuroendocrinology.  Under general supervision of the Principal Investigator and/or Nurse Practitioner, the incumbent will carry out a broad range of research activities and procedures with input into protocol design and some latitude to determine techniques and establish procedures.

 

Principal Duties and Responsibilities

 

Responsible for oversight of defined clinical protocols including advertising for the recruitment of study patients, scheduling clinical research study patients for testing on the General Clinical Research Unit and MIT GCRC Bone Density Center, screening normal volunteers and patients for study participation; arranging management of patients with general physician supervision.  Responsible for reviewing lab results to ensure that protocol requirements are met and that abnormalities are addressed; collecting and collating data from numerous sources including Clinical Chemistry Lab, Radiology, Thyroid/Endocrine Lab, and Clinical Research Unit Core Lab; maintenance of primary data in research databases and patient charts (lab results, radiology reports, bone density); management of data generated by research protocols; and coordination of feedback to P.I.s.

 

Synthesizes and interprets information obtained from the sources mentioned above to prepare statistical and graphic summaries of findings and conclusions; collaborates with supervisor in writing and editing material for publication; prepares protocols for review by the required Hospital subcommittees (SHS, Pharmacy, GCRC, SRRP, IRB); prepares annual reports for renewal of the IRB Approval for human studies.

 

Collaborates with supervisor and computer support personnel to create and maintain a database for help in management of the information from the clinical protocols with the object of becoming a resource for teaching of other personnel within this Unit.  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 and slides for manuscripts and oral presentations.

 

Specific Duties:

  • Files, xeroxes, performs word processing
  • Orders supplies, schedules study appointments, processes checks and sets up meetings
  • Escorts patients to appointments
  • Ships and stores specimens
  • Collects and organizes patient data
  • Uses software programs to generate graphs and reports
  • Assists with recruiting patients for clinical trials
  • Obtains patient study data from medical records, physicians, etc., using HIPAA guidelines
  • Conducts library searches
  • Verifies accuracy of study forms
  • Updates study forms per protocol
  • Maintains study codes
  • Assists with formal audits of data
  • Assists with interviewing study subjects
  • Provides basic explanation of study
  • Performs study procedures such as phlebotomy, EKG, Holter monitoring, etc.
  • Assists with study regulator submissions
  • Writes consent forms
  • Verifies subject inclusion/exclusion criteria
  • Maintains research data, patient files, regulatory binders and study databases
  • Performs data analysis and QA/QC data checks
  • May develop systems for QA/QC
  • Organizes and interprets data
  • Independently judges suitability of research subjects
  • Develops and implements recruitment strategies
  • Acts as study resource for patient and family
  • Monitors and evaluates lab and procedure data
  • Administers/scores/evaluates study questionnaires
  • Acts as liaison between Research Affairs and Unit
  • Files adverse events with IRB
  • Prepares for annual review
  • Recommends protocol changes and may assist with writing protocols and manuscripts
  • Works with PI to prepare complete study reports
  • Attends weekly clinical research meetings with staff and P.I.
  • Assists with transfer, accountability, and destruction, of investigational product, including controlled substances, in clinical trials under proper supervision of registered physician investigator.

Weekend and/or evening hours are required when needed.

Requirements

Qualifications
 Bachelors Degree
1 year of clinical research experience 
 EEO Statement 

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. 

 

Primary Location

: MA-Boston-MGH Main Campus

Work Locations

: 
MGH Main Campus 
55 Fruit Street 
 Boston 02114

Job

: Clinical

Organization

: Massachusetts General Hospital(MGH)

Schedule

: Full-time
Standard Hours: 40

Shift

: Day Job

Employee Status

: Regular
Recruiting Department: MGH Neuroendocrine

Job Posting

: May 1, 2017