The Clinic Research Operations Manager (Research and Innovation) will be responsible for supporting multiple strategic programs that are outlined in FARE’s 5-year strategic plan. This person will be an integral team member and will be expected to play multiple different roles to help support the execution of the strategic plan. The Manager will also support the on-going development, tracking, and implementation of the broader FARE research strategy which will be updated on an annual to semi-annual basis.
This role will report directly to the Senior Director of Program Management (Research and Innovation).
ESSENTIAL DUTIES AND RESPONSIBILITIES
Manages activities associated with highly complex biomedical research including investigator- and industry-initiated studies. Tracks and maintains study timelines.
Directly interfaces with clinical research coordinators and site staff who support FARE-funded clinical research. Assures protocol adherence and compliance by providing oversight and advisory support to individual coordinators.
Collaborates with Data Coordinating Center to provide Site Initiation Visits and routine staff meetings with agenda-driven objectives and training components.
Serves as the contact for completion of sponsor surveys and Sponsor Site Selection visits.
Contributes to the development of study budgets.
Understands interprets and explains protocol requirements to others.
Provides direct support for Principal Investigator and research coordinator during external audits.
Provides ongoing internal monitoring of quality and compliance both by informal and scheduled assessments of work products at specified time points. Identifies non-compliance events and guides corrective actions. Develops training or improvement plans.
Conducts study feasibility analysis for proposed new trials.
Assists in the development and maintenance of defined systems for implementation of protocols, including templated source document forms, recruitment strategies, supply inventories, Manual of Procedures, etc.
Under supervision, may design scientific communications within the company.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
The ideal candidate will be attracted to the opportunity to be a part of a world-class team that is doing something to truly change the world for food allergy individuals.
Key qualifications and skills include:
Familiarity with the regulated R&D process for new therapies (foods and drugs), diagnostics, and other medical solutions.
Excellent project management skills and ability to manage multiple, time-sensitive projects with competing demands for resources.
Ability to successfully engage internal and external stakeholders (at various levels and across functions) on new ideas. Must have superior interpersonal skills.
Must have general, functional expertise to support standard operating procedure (SOP) development and implementation.
Highly organized and process-oriented.
Must possess strong English communication and writing skills and be able to work independently and as part of a team.
Working knowledge and experience with Word, PowerPoint, and Excel.
EDUCATION AND EXPERIENCE
Bachelor’s degree required. Degree in health-related, biomedical, or social science field preferred.
Master’s degree preferred.
A minimum of 10 years of clinical research and project management experience required.
Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent highly preferred.
Understanding of regulatory processes associated with drug development and approval of foods required.
Experience with food allergy research, multisite clinical trials, and patient registries highly desirable.
Must have legal authorization to work in the United States.
FARE is dedicated to building an inclusive workforce where diversity is valued.
FARE is an equal opportunity employer. Every qualified applicant will be considered for employment. FARE does not discriminate based on race, color, religion, gender, gender identity or orientation, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
About Food Allergy Research & Education
FARE’s mission is to improve the quality of life and the health of individuals with food allergies and to provide them hope through the promise of new treatments.
Our work is organized around three core tenets:
• LIFE. Support the ability of individuals with food allergies to live safe, productive lives with the respect of others through our education and advocacy initiatives.
• HEALTH. Enhance the healthcare access of individuals with food allergies to state-of-the-art diagnosis and treatment.
• HOPE. Encourage and fund research in both industry and academia that promises new therapies to improve the allergic condition.