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 trials

Competencies Required:

* Excellent communication skills

* Sound interpersonal skills and the ability to supervise others

* Ability to work independently and display initiative to introduce innovations to research study

* Ability to prepare/monitor budgets

* Ability to identify problems and develop solutions

* Ability to prioritize tasks and set deadlines

Primary Duties as Assistant Project Manager of a Clinical Trial:

1. Schedule SAFER interviews with sites
2. Obtain interview results from doctors, track results, and communicate results to sites and sponsors
3. Manage Rater Training using Excel, MGH LMS and RedCap
4. Manages creation of study deliverables, including SAFER Implementation Plan, Rater Training Plan, etc.
5. Organize and attend conference calls and distribute minutes accordingly
6. Attend Investigator and Sponsor Meetings as necessary
7. Submit study protocols, protocol amendments, and study staff certifications to the IRB
8. Coordinate and respond to audits by study sponsors

Other Tasks, As Required:

* Verifies accuracy of study forms

* Updates study forms per protocol

* Prepares data for analysis and data entry

* Assists with formal audits of data

* Assists with study regulatory submissions

* 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

* Acts as study resource for sites

* Prepares for FDA and IRB annual reviews

* Recommends protocol changes and may assist with writing protocols and manuscripts

* Works with PI to prepare complete study reports

* Responsible for quality control

* Designs research protocols in conjunction with PI

* Assists in the selection of study sites

* Tracks and analyzes trends across studies, study sites, and CTNI clinicians

* 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 teams

* Facilitates any rater communication with study sites as requested

* Creates/distributes study reminders

* Acts as general resource for study information

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