Responsibilities:

Reporting to, and working closely with, our Program Manager and Principal Investigators, the Project Manager will be responsible for project management of the National Pregnancy Registry for Psychiatric Medications, the largest prospective study of the reproductive safety of antidepressants, atypical antipsychotics, psychostimulants, and other classes of psychiatric medications. The project team consists of three full-time clinical research coordinators, two or more undergraduate interns, the program manager, and study investigators.

Research

• Oversee regulatory compliance with IRB, FDA, and sponsor guidelines.
• Oversee adverse event and serious adverse event monitoring per protocol and in accordance with MGH research policies.
• Assist with the preparation and timely communication of progress reporting and deliverables to study sponsors.
• Invoice current study sponsors and assist with contract renewals.
• Perform outreach to new study sponsors and assist with establishing contracts.
• Prepare protocol documents and project budgets for sub-analyses and ancillary studies.
• Oversee database management and regulatory binders.
  • Responsible for quality control of a prospective pharmacovigilance study.
  • Develop and operationalize a QA/QC plan for cleaning and maintenance of a large REDCap database.
  • Develop and operationalize process and performance improvement projects for existing database.
  • Perform data quality audits on a regular basis to improve reliability of database.
  • Create REDCap reports and perform data extraction for relevant analyses.
  • Perform data cleaning and descriptive analyses.
  • Coordinate data analysis with staff biostatistician.
• Supervise the preparation and submission of poster presentations and manuscripts.
  • Prepare and review methods and analytic plans.
  • Prepare study abstracts and posters for conferences.
  • Review and prepare manuscripts for submission.
• Manage ongoing data collection of a prospective pharmacovigilance study.
  • Manage the screening and enrollment of research patients.
  • Conduct study visits and manage electronic deployment of surveys.
  • Perform data collection and entry.
  • Develop marketing strategies and oversee new and existing recruitment initiatives.
• Present and participate in regular meetings with operations and clinical research teams.
  • Coordinate logistics for meetings and conferences.
  • Prepare relevant meeting materials, including agendas, presentations, and minutes.

Personnel Management

• Provide day-to-day research supervision of study’s clinical research coordinators and several undergraduate interns.
• Act as a key point of contact for project staff to provide direction and guidance regarding day-to-day issues and activities.
• Oversee orientation and training for the project’s clinical research coordinators and research volunteers.

Web Administrator

• Primary support person for Editor-in-Chief of womensmentalhealth.org.
• Develop and post new website content.
• Track, compile, and analyze web site usage data.
• Manage and develop content for social media channels.

Work Environment:

Currently, our group is made up of seven research coordinators, a program manager, program coordinator, biostatistician, psychologist, and eleven psychiatrists. Three of our faculty are principal investigators, including the Director. The research coordinators and program team work closely with the study principal investigators and meet twice weekly as a group to review study progress. The group meets once a week for two hours to review clinical cases and ongoing research progress. This is a full-time hourly position with a 9:00-5:30 workday and a ½ hour unpaid lunch. Our Program is located in the Simches Research Building in a combined administrative and clinical space.

Note: Relocation to Boston is required for this position.

Qualifications:

We are looking for candidates who possess a graduate degree with 3 years research and data management experience. Experience with REDCap databases and regulatory/IRB submissions is preferred.

This position is ideal for someone with previous experience as a clinical research coordinator or research assistant who is interested in further developing skills in data and research project management, with future ambitions of pursuing graduate studies in statistics, epidemiology, or health sciences. A two-year commitment is strongly preferred.

Skills:

• Strong organizational skills and attention to detail; love of data and improvement projects.
• Ability to prioritize and resolve critical issues efficiently and effectively.
• Ability to effectively present ideas, information, and roadblocks.
• Ability to work independently and self-manage; ability to lead and coordinate others.
• High degree of initiative and enthusiasm for learning new concepts and working with new tools and sources of information.
• Data cleaning skills with either R, Stata, or SAS, and prior experience working with statisticians is advantageous.