Tufts Medicine Supervisor Clinical Trials in Boston, Massachusetts
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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 clinical research towards solving a specific problem for an entity or community. A management role that supervises employees focusing on tactical, operational activities within a specified area, with the majority of time spent overseeing area of responsibility, planning, prioritizing and/or directing the responsibilities of employees. Goal achievement is typically accomplished through performance of direct and/or indirect reports. A role that supervises all levels of employees. Responsibilities that typically include: Setting goals and objectives for team members for achievement of operational results, problems faced may be difficult but typically are not complex, and ensures policies, practices and procedures are understood and followed by direct reports, customers and stakeholders.
This position is responsible for the development, implementation, management, and administration of the various industry and federally funded clinical trial protocols. This position meets regularly with Principal Investigators 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.
Clinical certifications, licenses, and/or registrations relevant to clinical trial such as Registered Nurse (RN).
Five (5) years of relevant experience.
Experience in clinical trial award set up, close out, and reconciliations.
Master’s degree relevant to clinical trial.
Clinical certifications, licenses, and or registrations relevant to clinical trial such Nurse Practitioner (NP), or Physician Assistant (PA).
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.
Responsible for the supervision (hiring, training and performance evaluation) of clinical trials staff.
Disseminates information on available clinical trials in written and oral formats to Research Investigators.
Maximizes accrual onto clinical studies by serving as a liaison to physicians and fellows to answer protocol-related questions and to facilitate patient screening/entry into clinical trials.
Coordinates and manages patient recruitment.
Interacts with Principal Investigators (PI’s) and study staff to ensure compliance with 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.
Represents the PI and hospitals to others and interacts effectively with personnel at all levels.
Develops and maintains IRB certification for ongoing and new studies.
Assists with design of databases and database functions and the creation of new databases or improvement of existing databases.
Assists 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.
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.
Works with PI’s to develop short and long term planning objectives for the clinical trials office.
Works as a liaison with hospital’s IRB and WIRB to facilitate approval of projects and ongoing documentation and reporting.
- Typical clinical and administrative office setting.
Skills & Abilities:
Highly self-disciplined, motivated and capable of self-direction within a defined scope of work.
Knowledge of FDA and CFR regulations.
Ability to be meticulous and detail-oriented.
Ability to interpret and apply sponsor, institutional and departmental policies and interpret policy for others.
Excellent written and oral communication skills.
Strong computer skills, including proficiency with MS Office (Word, Excel and Power Point), and familiarity with databases (e.g., experience using MS Access).
Computer programming, database, and statistical analysis skills.
Strong organizational skills with the ability to handle competing demands in order to meet project timelines.
Ability to work independently and collaborate within a team environment.
Ability to multi-task and prioritize responsibilities as needed.
Ability to conduct medical literature searching and retrieval.
Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network. We are an equal opportunity employer and value diversity and inclusion at Tufts Medicine. Tufts Medicine does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation by emailing us at firstname.lastname@example.org .