Massachusetts General Hospital(MGH)
Clinical Trial Asst Proj Manager
Massachusetts General Hospital(MGH), Boston, Massachusetts, us, 02298
Expectations for All Employees:
Supports the organization's missions, vision and values by exhibiting the following behaviors; excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, and accountability and ownership
Position Summary:
Assists with coordination of CTNI-managed clinical trial
Competencies Required:
* Excellent communication skill
* Sound interpersonal skills and the ability to supervise other
* Ability to work independently and display initiative to introduce innovations to research study
* Ability to prepare/monitor budget
* Ability to identify problems and develop solution
* Ability to prioritize tasks and set deadline
Primary Duties as Assistant Project Manager of a Clinical Trial:
Schedule SAFER interviews with sites Obtain interview results from doctors, track results, and communicate results to sites and sponsors Manage Rater Training using Excel, MGH LMS and RedCap Manages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc. Organize and attend conference calls and distribute minutes accordingly Attend Investigator and Sponsor Meetings as necessary Submit study protocols, protocol amendments, and study staff certifications to the IRB Coordinate and respond to audits by study sponsors
Other Tasks, As Required:
* Verifies accuracy of study form
* Updates study forms per protocol
* Prepares data for analysis and data entry
* Assists with formal audits of data
* Assists with study regulatory submission
* Verifies subject inclusion/exclusion criteria
* Maintains research data, patient files, regulatory binders and study database
* Performs data analysis and QA/QC data check
* May develop systems for QA/QC
* Acts as study resource for site
* Prepares for FDA and IRB annual review
* Recommends protocol changes and may assist with writing protocols and manuscript
* Works with PI to prepare complete study report
* Responsible for quality control
* Designs research protocols in conjunction with PI
*
Assists in the selection of study site
* Tracks and analyzes trends across studies, study sites, and CTNI clinician
* Invoices sponsors and processes payments to vendors
* Orders supplies, handles computer and telephone issues, and communicates with property management
* Participates in regular meetings with operations and clinical team
* Facilitates any rater communication with study sites as requested
* Creates/distributes study reminder
* Acts as general resource for study information
Work Schedule:
Monday through Friday, 9:00AM to 5:30PM
Working Relationships:
Must be able to communicate well both verbally and in writing with internal and external client
Qualifications
Requirements:
BA or BS
Minimum of 1-3 years of work experience, clinical research experience helpful
Must be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, PowerPoint, Access, Outlook) and Internet communication
Familiarity with statistical packages (SPSS, SAS) desirable
Must have the capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriate
EEO Statement
Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Supports the organization's missions, vision and values by exhibiting the following behaviors; excellence and competence, collaboration, innovation, respect, personalization, commitment to our community, and accountability and ownership
Position Summary:
Assists with coordination of CTNI-managed clinical trial
Competencies Required:
* Excellent communication skill
* Sound interpersonal skills and the ability to supervise other
* Ability to work independently and display initiative to introduce innovations to research study
* Ability to prepare/monitor budget
* Ability to identify problems and develop solution
* Ability to prioritize tasks and set deadline
Primary Duties as Assistant Project Manager of a Clinical Trial:
Schedule SAFER interviews with sites Obtain interview results from doctors, track results, and communicate results to sites and sponsors Manage Rater Training using Excel, MGH LMS and RedCap Manages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc. Organize and attend conference calls and distribute minutes accordingly Attend Investigator and Sponsor Meetings as necessary Submit study protocols, protocol amendments, and study staff certifications to the IRB Coordinate and respond to audits by study sponsors
Other Tasks, As Required:
* Verifies accuracy of study form
* Updates study forms per protocol
* Prepares data for analysis and data entry
* Assists with formal audits of data
* Assists with study regulatory submission
* Verifies subject inclusion/exclusion criteria
* Maintains research data, patient files, regulatory binders and study database
* Performs data analysis and QA/QC data check
* May develop systems for QA/QC
* Acts as study resource for site
* Prepares for FDA and IRB annual review
* Recommends protocol changes and may assist with writing protocols and manuscript
* Works with PI to prepare complete study report
* Responsible for quality control
* Designs research protocols in conjunction with PI
*
Assists in the selection of study site
* Tracks and analyzes trends across studies, study sites, and CTNI clinician
* Invoices sponsors and processes payments to vendors
* Orders supplies, handles computer and telephone issues, and communicates with property management
* Participates in regular meetings with operations and clinical team
* Facilitates any rater communication with study sites as requested
* Creates/distributes study reminder
* Acts as general resource for study information
Work Schedule:
Monday through Friday, 9:00AM to 5:30PM
Working Relationships:
Must be able to communicate well both verbally and in writing with internal and external client
Qualifications
Requirements:
BA or BS
Minimum of 1-3 years of work experience, clinical research experience helpful
Must be knowledgeable about computers and data management systems and familiar with common software packages (Word, Excel, PowerPoint, Access, Outlook) and Internet communication
Familiarity with statistical packages (SPSS, SAS) desirable
Must have the capability of prioritizing multiple competing tasks and seek supervisory or administrative assistance when appropriate
EEO Statement
Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.