We offer competitive salaries, and for those who qualify, an excellent benefits package; including comprehensive medical and dental insurance plans, and a retirement plan with employer match. We also provide 12 paid holidays, paid vacation, and more.
Internal Number: TFI-22-FT-16
Under the direction of the Director of Clinical Research, and in collaboration with the Medical Research Director, and other study principal investigators, the Operations Director, Clinical Trials will direct and coordinate high-quality administrative and study operations for DAIDS funded and industry-sponsored studies taking place at TFI.
Provides supervision and training to assigned staff
Develops, implements, and coordinates orientation and relevant trainings for new biomedical team staff to support knowledge transfer of research process and regulations.
Provides ongoing assessment of staff training needs throughout the course of clinical research studies.
Communicates regularly with study clinicians, MDs, and PIs regarding laboratory and clinical findings as they relate to meeting regulatory and study monitoring reporting requirements
Guides study staff in troubleshooting research issues and problems raised by sponsors, funders, and collaborators.
Provides supervision and training to 3-5 staff members as assigned.
Oversees the Operations and Implementation of DAIDS Clinical Research Studies and Projects
Oversees the staff who prepare submission of research proposals for Investigational Review Board (IRB) review.
Supports the development and review of standard operating procedures (SOP’s) for use by all relevant personnel
Supports the development and review of budgets and justification submissions.
Regularly reviews study project workflow, timelines, and resource needs to ensure efficient and high-quality work is performed; utilizes key performance indicators to monitor progress.
Plans and leads operations team meetings and trainings
Facilitate study initiation and site monitoring visits or supports staff in doing so.
Supports study staff to manage study specific regulatory documents according to the guidelines of FDA, DAIDS, HHS, NIH and/or study sponsor
Oversees and supports the site activation process and related activities
Works with the recruitment team to ensure target goals are planned for and met on time.
Actively participates or delegates participation on all study-related conference calls and study specific operations meetings and trainings.
Meets with the PI as needed to review adherence to the project design, conduct of the project, staffing issues, and the fidelity and quality assurance of the interventions
Manages staff scheduling and the general study visit schedule to ensure staffing and resource needs and participant engagement.
Participates in weekly huddle meetings with the recruitment and community engagement team
Supports study close-out activities, inclusive of dissemination of study results to participants and stakeholders and relevant communication to regulatory authorities and Sponsors.
Oversees Data Collection, Dissemination and Quality
Reviews project-specific systems and designs, and implements new systems to ensure and enhance project efficiency.
Ensures research staff are trained and utilizing data management systems as instructed.
Works with regulatory staff to oversee and evaluate development of and compliance with quality management plan for all studies.
Provides training to study staff on quality management of specific protocols/networks and ensures, along with Regulatory Manager, that the quality management plan is being followed.
Perform annual review of DAIDS Data Quality Management Plan, Laboratory Quality Management Plan and Pharmacy SOPs
Supports Study Visits Using Established Protocols
Reviews and discusses the informed consents with clients.
Serves as a backup staff member for performing specified research procedures according to study protocols, including phlebotomy, specimen processing, collection of vital signs, HIV testing and risk reduction counseling, behavioral interviewing and others as protocol specifies.
Provides telephone triage for study participants.
Provides technical assistance and oversight to other research staff who are performing study procedures with support of study clinician.
Accurately Documents Study Activities
Oversees the development of protocol specific source documents and case report forms by study leads as necessary.
Supports site monitoring visits; provides assistance to the Regulatory Manager, Data Manager, and Study Coordinators during on-site and remote monitor visits
Monitors network-expected training updates, and provides guidance and in-house training opportunities to staff.
Assesses overall quality and efficiency of program operations; modifies procedures or collaboratively develops new tools with the study team as necessary.
Serve as a leader for the Research Department
Work with other department leaders to develop, implement, and coordinates orientation and relevant trainings for research staff to support knowledge transfer of research process and regulations.
Coordinate with TFI leaders to share information about relevant trainings to TFI staff in general.
Work with department directors to update Standard Operating Procedures as well as training documentation and processes
Serve as supervisor for 8th floor receptionist
Meets Agency Participatory Expectation
Adheres to all agency and departmental policies and procedures
Participates in quality assessment and improvement activities as requested
Adheres to the highest principles of patient and client confidentiality
Adheres to established safety policies, procedures and precautions; identifies potential or actual unsafe situations in the environment and takes measures to rectify the situation
Attends all required meetings, in-services and professional trainings
Maintains professional competence necessary to perform job responsibilities; maintain and provides agency with records of continuing education activities.
Serves on agency committees and in professional organizations when requested.
LGBTQIA+ identified persons, Black, Indigenous, and other people of color (BIPOC), and individuals from other historically underrepresented communities are strongly encouraged to apply.
Bachelor’s Degree, preferred
Master of Public Health or other Master’s Degree-level education in related field preferred
At least five years of relevant research experience preferred
Project management experience required
Supervisory experience required
Excellent writing skills required
Working knowledge of HIV pathophysiology, prevention, and treatment required
Attention to detail is extremely important
Ability to function autonomously in a collaborative team
Familiarity working with populations at risk for HIV infection.
Experience working in an ethnically, culturally, and racially diverse work staff.
Ability to work harmoniously with diverse groups of individuals required.
Working knowledge: Microsoft Outlook, Word, Excel, Access, PowerPoint.
The mission of Fenway Health is to enhance the wellbeing of the lesbian, gay, bisexual and transgender community and all people in our neighborhoods and beyond through access to the highest quality health care, education, research and advocacy.