• Employment Type: Full Time
• Shift: Days
• Hours: 8-4:30
• Location: Boston, MA

This position is responsible for the development, implementation, management and administration of the various industry and federally funded clinical trial protocols in the Ophthalmology Department. Position will meet weekly with Physician Director of Clinical Research to discuss updates, performance of other clinical research staff, tasks of other clinical research staff, organization for all new clinical trials, performance on current trials, IRB status on all ongoing activities, enrollment and of all trials and how to accelerate. Position will interface with sponsors, monitoring organizations, and departmental and non-departmental personnel to assure a collaborative environment and high quality outcomes. Responsible for assisting with budget preparation in collaboration with Research Administration and working with hospital Clinical Research Office regarding contracting and IRB approvals.

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

• In conjunction with Department Research Investigators, responsible for the supervision (hiring, training and performance evaluation) clinical trials staff.
• Disseminates information on available clinical trials in written and oral formats to Research Investigators.
• Maximize accrual onto clinical studies by serving as a liaison to physicians and fellows at TMC to answer protocol-related questions and to facilitate patient screening/entry onto clinical trials.
• Coordinate and manage patient recruitment.
• Interacts with Principal Investigators (PI) and study staff to assure compliance to study protocols and requirements.
• Oversees and organizes data collection and Clinical Study Coordinator activities to monitor quality accuracy, and timeliness of data submission.
• Reviews proposed protocols with investigators to assess feasibility of undertaking projects.
• Assists in the opening of new studies and creating patient consent forms as needed.
• The ability to represent the PI and TMC to the affiliate hospital and deal effectively with personnel at all levels. Works with PIs to develop short and long term planning objectives for the clinical trials office.
• Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment
• Performs other similar and related duties as required or directed.
• Development and maintenance of IRB certification for ongoing and new studies, as requires. Work as a liaison with Tufts Medical Centers IRB and WIRB to facilitate approval of projects and ongoing documentation and reporting.
• Assists with design of databases and database functions and the creation of new databases or improvement of existing databases.
• Assist in production of materials for research reports and presentations, which may include drafting, editing, formatting, copying, collating, and/or mailings.
• Prepares summaries of peer comments and coordinates activities with researchers to make report changes which are responsive to peer comments.
• Responsible for online submission of manuscripts.

JOB KNOWLEDGE AND SKILLS:

• Prior experience with the conduct of major clinical trials.
• High degree of organizational, data management and analytical skills.
• Requires meticulous attention to detail.

EDUCATION:

• Bachelors degree or level of knowledge generally obtained through a bachelors degree in science, business administration, Master in Public Health degree preferred, and/or healthcare administration.

EXPERIENCE:

• Minimum 5 years in research environment.
• Expert knowledge of medical literature searching, and retrieval required. Expert knowledge of internet-based searching.
• Demonstrated proficiency in computer applications including word processing (Microsoft Word or Word Perfect), spreadsheets such as Excel, database managers such as Access and reference software such as Endnote.
• Strong writing skills and experience
• Skill in communication and participation in a team process.
• Highly self-disciplined, motivated and capable of self-direction within a defined scope of work.
• Experience with IND filings highly desirable

AGE SPECIFIC COMPETENCIES:

• Possesses and applies the skills and knowledge necessary to provide care to patients throughout the life span, with consideration of aging processes, human development stages and cultural patterns in each step of the care process. This includes:
• Knowledge of growth and development
• Ability to interpret age specific data and response to care
• Provide age specific communication

WORKING CONDITIONS/PHYSICAL DEMANDS:

• Normal Office Environment

All your information will be kept confidential according to EEO guidelines.

AMERICANS WITH DISABILITIES STATEMENT:

Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

COVID-19 POLICY:

Please note that effective October 1, 2021, as a condition of employment at Tufts Medical Center, all employees and new hires must have received their complete dose of the COVID-19 vaccine, unless they have been granted an exemption.