Job Description:

I. Position Summary: 

The Project Director will perform a wide variety of duties to help the Principal Investigator  conduct and coordinate all phases of NIH-funded STARS clinical trial. Facilitates and coordinates daily study activities, including participant recruitment, enrollment, data collection, tracking, monitoring progress and collaborating with the team both within the institute as well as with teams at other institutes to ensure successful progress and completion of all study aims. Works with the Principal Investigator, department, sponsor, and institution to support and provide guidance on the administration of compliance, financial, personnel and other related aspects of the study. Must have the ability to work on multiple tasks, prioritize them, develop workflow, and meet study deadlines. Must be able to work with minimal supervision, be self-motivated, able to work independently and as a part of a team. Must have good problem-solving skills, be able to provide leadership to the team when required and oversee the work of research assistants in the field. The project director will assist in the creation and management of appropriate infrastructure necessary to support clinical research programs and research activities. The Project Director will work under the direction of and report to the Principal Investigator. 3-7 years’ experience necessary. Master’s degree preferred.

II. Core Competencies:

• Results Orientation: Focuses on delivering superior performance by setting and achieving stretch goals.
• Organizational Know-how-understands and uses formal structure, important relationships, and culture within HSL and with external customers to accomplish work objectives and outcomes.
• Teamwork and Collaboration: Works effectively within a team, group and across the organization and accomplishes tasks and desired results while behaving constructively as opposed to separately and competitively.
• Managing Complexity: Uses experience, knowledge, and training to manage effectively in increasingly difficult and ambiguous situations, making the best decisions possible at the time.

III. Position Responsibilities:

The Project Director will perform a wide variety of duties to help Principal Investigator coordinate all phases of clinical research, assist in the creation and management of appropriate infrastructure necessary to support clinical research programs and research activities. The Project Director will work under the direction and report to the Principal Investigator.

• The ideal candidate will have had formal training in Good Clinical Practice for Clinical Trials Research and prior experience in the direction of rigorous and complex funded clinical research projects, preferably clinical trials. Prior experience creating instruments for electronic data collection (EDC) and implementing and managing EDC management system is an asset. An understanding of clinical research pertinent to older adults would be considered an asset. Qualification should also reflect skills in the responsibilities outlined below:

• The candidate is expected to work within the limits of standard research practice and follow established policies and procedures when executing the all responsibilities. These responsibilities will include the activities in the following areas: organization of study start-up (writing  standard operating procedure (SOP) manual, development of electronic data collection tools, broad study organization), conduct and execution of study protocol (recruitment, enrollment, scheduling of study visits, completion of study visits for data collection and live data entry into REDCap, randomization, fidelity to intervention, proper handling of blood samples for labeling, storage, and shipping).
  
• Expected to work in-person five days a week to ensure effective study operations. Ensure that study clinic has study related supplies and that the clinic operates per the institute’s guidelines. Train, orient, and oversee the work of research assistants, according to established protocols and procedures.
  
• Responsible for preparing agendas, drafting minutes of meetings, facilitating discussion, and providing updates, addressing any questions, and resolving issues that may arise. This includes creating and tracking work orders (in project management application - Jira) to monitor data management activities.
  
• Oversee data management including data cleaning and tracking in collaboration with biostatistics team (ensure electronic data capture aligns with manual of operations). Prepare tracking reports to be shared with principal investigators and study staff.
  
• Work with grants management to maintain and provide reports related to participant compensation. Ensure all study related invoices are paid and reimbursements are submitted in a timely manner.
  
• Function as a liaison with the teams at Beth Israel Deaconess Medical Center (BIDMC) Radiology, Harvard Chan School of Public Health (HSPH) and other institutes and testing centers to ensure efficient communications and completion of activities related to the STARS clinical trial. For e.g., regularly obtain screening blood test results from the lab test center, receive completed forms from HSPH, pick up bone scans from the BIDMC radiology center, and transfer the scans to another institute for analysis.
  
• Coordinate and attend all regular study meetings and prepare documents and reports to the Institutional Review Board (IRB) and Data Safety and Monitoring Board. When executing these responsibilities, he/she will ensure regulatory compliance including both governmental (NIA, FDA) and institutional (IRB), Office of Human Subjects Protection (OHRP) and adherence to HIPAA regulations. He/she will assure that informed consent is obtained, and when working with older adults, following established governmental guidelines for research with vulnerable populations. 
  
• Coordinate and attend all regular study meetings and prepare documents and reports to the Institutional Review Board (IRB) and Data Safety and Monitoring Board. When executing these responsibilities, he/she will ensure regulatory compliance including both governmental (NIA, FDA) and institutional (IRB), Office of Human Subjects Protection (OHRP) and adherence to HIPAA regulations. He/she will assure that informed consent is obtained, and when working with older adults, following established governmental guidelines for research with vulnerable populations. The above covers the most significant responsibilities of the position. It does not, however, exclude other duties, which would be in conformity with the level of the position. Completes special projects as assigned. 
  
• Will review, evaluate, and make verbal or written reports as directed by his/her supervisor and perform special projects or other related duties as responsibilities necessitate. As a member of HSL’s Hinda and Arthur Marcus Institute for Aging Research, will agree to occasionally serve as a consultant to Marcus Institute principal investigators and provide functional leadership to institute research coordinators to facilitate/plan successful studies.
  
  The above covers the most significant responsibilities of the position. It does not, however, exclude other duties, which would be in conformity with the level of the position. Completes special projects as assigned.

• 3-7 years’ experience necessary. Master’s degree preferred.
• Expert interpersonal skills are required to guide and encourage complete participation in study protocols and to forge and maintain productive working relationships with participants, families, research team members, internal and external collaborators and vendors, and others. Must be comfortable working with older study participants.
• Have excellent computer skills including ability to communicate with email, use MSWord, MS Excel, MS PowerPoint, Pub Med searches, and internet applications for online meetings. Must have solid foundation on electronic data capture systems.

• Must have the ability to work on multiple projects, prioritize tasks, develop workflow, and meet study deadlines. Must have previous experience with data collection, data validation, and data management.

• Working knowledge of the regulations governing the conduct of human studies research. Must demonstrate respect and professionalism regarding subjects’ rights, individual needs, and a working knowledge of HIPAA Protected Health Information regulations.
• Must be extremely self-motivated, and detail oriented with excellent problem-solving skills.
• Must be able to demonstrate ability to be flexible, must be able and willing to adapt to change and learn new technologies.
• The ability to work as part of a cohesive team is essential.

• Must be professional, proactive, collaborative, conscientious and results-oriented individual. Must have an optimistic and positive demeanor, excellent oral and written communication skills, good intuition and able to adapt to changing priorities and display good, sound judgment with a sense of humor.

• The ability to work as part of a cohesive team is essential.

V Physical Requirements:

See physical requirements sheet in OH.

Remote Type:

Salary Range: