Job Profile Summary This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. A senior level role that requires advanced knowledge of job area typically obtained through advanced education and work experience. Typically responsible for: managing projects / processes, working independently with limited supervision, coaching and reviewing the work of lower level professionals, resolving difficult and sometimes complex problems. Job Overview This position is responsible for the implementation, management and administration of clinics trial protocols. This position will manage a team of research coordinators and interface with federal sponsors, inpatient and outpatient facilities, departments and personnel to assure collaborative environment and high-quality study enrollment and outcome(s). Job Description Minimum Qualifications: 1. Bachelor’s degree 2. Clinical certifications, licenses, and or registrations relevant to clinical trial such as Registered Nurse (RN) 3. Seven (7) years of relevant experience Preferred Qualifications: 1. Master’s degree relevant to clinical trial. 2. Clinical certifications, licenses, and or registrations relevant to clinical trial such Nurse Practitioner (NP), or Physician Assistant (PA). 3. Ten (10) years of relevant experience. 4. Previous research experience. Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned. 1. Reviews proposed protocols with Principal Investigators to assess the feasibility of undertaking the project. 2. Oversees recruitment and study conduct. 3. Develops and implements approaches to improve subject recruitment and study conduct performance. 4. Assists in preparation of IRB proposal, study documentation, budget, and resource/personnel allocation. 5. Works as a liaison with TMC's IRB to facilitate approval of projects and ongoing documentation and reporting. 6. Liaison with sponsor agency and monitoring personnel. 7. Interacts with PI and collaborating physicians, inpatient and outpatient facilities and personnel to comply with study protocols and requirements. 8. Coordinates and manages patient recruitment. Monitoring and documentation of care and progress. 9. Provides direct patient care including interviewing to obtain relevant historical, medical personal and physical data for patient data collection forms. 10. Collects and handles research specimens. Stores and mails as necessary for various protocols. 11. Records test results, accurately and timely, in research record and patient hospital/clinic records, and case report forms. 12. Provides patient education in the form of written and verbal instructions to the patient for diary keeping, medication usage and protocol compliance. 13. Trains, supervises and oversees other personnel. 14. Meets deadlines for submission of clinical related specimens and/or documentation. Physical Requirements: 1. Typical clinical and administrative office setting. Skills & Abilities: 1. Experience in clinical trial award set up, close out and reconciliations. 2. Knowledge of FDA and CFR regulations. 3. Be meticulous and detail-oriented, be able to communicate with peers as well as investigators. 4. Ability to interpret and apply sponsor, institutional and departmental policies and interpret policy for others. 5. Excellent written and oral communication skills. 6. Strong computer skills, including proficiency with MS Office (Word, Excel and Power Point), and familiarity with databases (e.g., experience using MS Access). 7. Computer programming, database, and statistical analysis skills. 8. Strong organizational skills with the ability to handle competing demands in order to meet project timelines. 9. Ability to work independently and collaborate within a team environment. 10.Ability to multi-task and prioritize responsibilities as needed. 11. Ability to conduct medical literature searching and retrieval required. 12. Highly self-disciplined, motivated and capable of self-direction within a defined scope of work. Tufts Medicine is a leading integrated health system bringing together the best of academic and community health care to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Healthcare, an expansive home care network and a large clinically integrated physician network, Tufts Medicine has more than 15,000 dedicated employees and caregivers. The health system came together in 2014 to leverage the experience of its member organizations and integrate their missions to together transform the ways that consumers engage with and experience their care.