Project Director Research-PT

Job Profile Summary

The Clinical Trials Project Director will report to and work closely with the PrincipalInvestigator 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 inthe following areas: project management, data monitoring, biostatistics and safetysurveillance, human investigation requirements, clinical care, disease processes andpractical clinical trial applications.

In specific, the N-of-1 Project Director will possess skills, knowledge and experience inthe 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 ongoingfeedback of team's efficiency and N-of-1 stakeholder effectiveness. He/she/they willcollaborate with research administration to develop N-of- clinical trial budgetsspecifically, communicating and coordinating with insurance payers, Tufts Grants andContracts and Legal to ensure budgets are consistent with agreed upon allocation ofpayments 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 resourcesand ensure compliance on multiple levels as related to the scientific goals and trial'soutcomes.

*This is an onsite position at 24 hours a week.

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, in addition to some clinical trials exposure.

Preferred Qualifications:

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

2. Clinical Research/Clinical Trial Operations experience.

3. 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.

4. 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.

5. 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.

1. Assist the Principal Investigator in the establishment and ongoing communicationand operational flow of the research activities between N-of-1 Team,Stakeholders, condition- specific co-investigators, clinical and research staff
2. Oversee implementation of training procedures that will be used to ensure equalstandards of learning for research staff. This person will assist the team to conducton-line training components in conjunction with the content and proceduralinvestigator experts from the trial. Will monitor and maintain status report resultsfrom the staff training and tracking system.
3. Assist in conducting in person group training sessions associated with all aspectsof the trial including patient enrollment, data collection and follow-up.
4. Monitor the site's adherence to the study protocol's human investigation
requirements to ensure that all investigators and research assistants complete theon-line NIH educational program for the protection of human research
participants and any additional HIPAA requirements.
5. He/she/they will monitor the output of research staff and pay close attention tooverall adherence to the timeline and milestones in order to meet the researchobjectives.
6. Will participate and lead N-of-1 Stakeholder Meetings, site meetings and
conference calls. Will travel to sites for start-up, training and additional meetingsor site visits as needed.

Physical Requirements:

1. This is largely a sedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.

2. Frequently required to speak, hear, communicate, and exchange information.

3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters, numbers and symbols.

4. Requires manual dexterity using fine hand manipulation to operate computer keyboard.

Normal office work environment. May interact with enrolling patients in outpatient setting

*This position is in person, but possible flexible as needs arise for remote days here and there.

Skills & Abilities:

1. Computer literacy including ability to use and understand databases.

2. Extensive knowledge of Quality Improvement, Evaluation and Error Reduction Systems in multiple settings (hospital, corporation, insurer) and the ability to design and lead implementation of the TIPI-IS Reporting System in any institution.

3. Strong interpersonal and leadership skills needed to interact with physicians, administrators, insurers, academic staff and support staff.

4. Excellent communications skills, both verbal and written, including the ability to independently incorporate information from various sources into newly created materials.

5. Knowledge of accounting and science literacy.

6. Outstanding attention to detail needed.

7. Strong organizational, developmental and analytical skills and the ability to anticipate programmatic needs required.

8. Knowledge of NIH policies.

9. Ability to lead and direct others by setting priorities for completion of multiple tasks.

10. Ability to maintain sensitive and confidential information.

11. Ability to be flexible with work schedule.

12. Maintains frequent contact with clinical and administrative staff at hospitals.

13. Ability to meet needs of competing demands simultaneously.