Project Director Research

Job Profile Summary 

The Clinical Trials Project Director will report to and work closely with the Principal Investigator in the coordination and management of the clinical trial operations for the Nof-1 Clinical Trial Program. 

In general this individual will possess varying components of expertise and knowledge in the following areas: project management, data monitoring, biostatistics and safety surveillance, human investigation requirements, clinical care, disease processes and practical clinical trial applications. 

In specific, the N-of-1 Project Director will possess skills, knowledge and experience in the following areas: 
• Leadership: Demonstrated ability to inspire, empower, and communicate 
effectively with stakeholders at all levels 
• Analytical skills: Demonstrated ability to analyze, think critically, and solve 
problems including ability to analyze logistical and operational challenges, 
continually revising project plans with rapid cycle change implementation 
• Project management: Demonstrated ability to manage multiple projects 
simultaneously and collaborate with cross-functional teams, including medical, 
nursing, and research staff across Tufts Medicine. 
• Research methodologies: Knowledge of research methodologies, statistical 
analysis, and data visualization tools and telehealth platform. 
• Risk management: Able and willing to proactively identify and mitigate risks to 
research participants, clinical team(s), data integrity and Federal Regulation 45 

The Project Director will collaborate with the Principal Investigator to provide ongoing feedback of team’s efficiency and N-of-1 stakeholder effectiveness. He/she/they will collaborate with research administration to develop N-of- clinical trial budgets specifically, communicating and coordinating with insurance payers, Tufts Grants and Contracts and Legal to ensure budgets are consistent with agreed upon allocation of payments as outlined in the study Informed Consent and IRB approval.

Other responsibilities of the N-of-1 project director may include: defining project 
objectives and scope, creating project plans, assembling and managing project teams, making critical decisions, and monitoring and adjusting finances

The Project Director will work with the research administration team to review resources and ensure compliance on multiple levels as related to the scientific goals and trial’s outcomes.

Job Description 

Minimum Qualifications: 

1. Adv degree in research-related or clinical field (RN, BSN, MSN, PharmD). 

2. Licenses, certifications, or registrations as appropriate. 

3. Five (5) years of experience in developing, managing, and evaluating hospital, health, or clinical programs. Ideally with Clinical Research/Clinical Trial Operations

Preferred Qualifications: 

1. Proficiency with Microsoft Office software, including Excel, Access, and Word.

2. Excellent judgment, poise, and tact, strong interpersonal skills, ability to handle a large number of competing demands simultaneously, attention to detail, and the ability to interact with a wide variety of personnel, departments, and organizations.

3. Candidate needs to have superior communication skills (both written and oral), organizational skills, project planning and management skills with a drive to meet deadlines. Candidate must be innovative, proactive, and motivated, with a focus on continuous improvement and a strong desire to succeed.

4. Ability to take initiative and in turn function at a high level of independence as demonstrated by independent decision-making, ability to solve problems, know when to ask for guidance, and the ability to represent the Project Director.

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. 

Assist the Principal Investigator in the establishment and ongoing