Clinical Research Project Manager

The primary responsibility for the Project Manager will be to coordinate IRB approval and regulatory documentation for all participating sites, as well as implement the study at MGH. The Project Manager will plan and implement study protocols, create standard operating procedures, collect, and manage study data, assist in study activities, perform systematic literature reviews, and synthesize relevant data. The candidate will also prepare study progress reports and presentations, and may provide support analysis and help with the preparation of manuscripts. Initial focus will be launching the study, IRB application, and ensuring each staff member is fully trained. The Project Manager will recruit and enroll patient in the clinical trial. They will be responsible for data entry and management. In addition, the Project Manager will manage invoicing for all active research studies; assist with coordination and development of budgets and contracts; develop appropriate databases for tracking scientific, financial, and administrative information; develop best practices; create SOP's; train new research staff members; as well as assist professional staff in the dissemination of research and operational efforts through presentations and written material. The position requires strong leadership and project development skills. While this is not a clinical position, it requires a good knowledge of basic clinical concepts and an understanding of how and when to communicate with clinicians. The Project Manager position requires the ability to be highly self-directing, resourceful, professional, and organized. The Project Manager will help ensure smooth communication and follow-up among all staff working with study subjects.

The candidate must demonstrate superior organizational, time management, and communication skills, as well as intellectual independence and initiative. He/she will protect confidential and sensitive research data with integrity. The ability to work both independently and as part of a team is essential to this job. Other job duties and responsibilities are listed in detail below. This is a full-time (40 hours/week) position; evening and occasional weekend hours will be required.

The incumbent will act as the critical liaison between the MGH Admin Core and the other 15 participating sites.

The Project Manager oversees the implementation of the protocol at the site and is responsible for oversight of all protocol functions and activities.

• Oversee regulatory affairs of the study
• Oversees regulatory affairs of the study, collates and files forms, documents, and other paperwork to set up and maintain research data (paper and electronic), patient files, and regulatory binders per FDA, IRB, and NIH standards
• Works with physicians and nurses to screen subjects for research study by reviewing patient data for eligibility; ensures patients referred meet study criteria
• Establish recruitment strategies and assure implementation and goal attainment on trials
• Oversee collection and integrity of study data
• Serve as a project administrator, working on systems improvement, project development and establishment of project SOPs
• Assist with expediting funding and study start-up at MGH and other participating centers
• May operate equipment to process blood samples; evaluates sample results to ensure correct processing; labels and ships specimens in compliance with regulatory and sponsor standards
• Research and clinical staff have successfully completed all required training and certifications and all staff follows GCP procedures
• The protocol is meeting recruitment, randomization, and follow-up targets
• Research study SOPs are followed, and study data are forwarded to the appropriate cores regularly
• AEs and SAEs are monitored properly and reported as defined in the protocol and in accordance with MGH research policies and the Partners IRB as necessary
• Ensures that annual IRB applications across all sites are submitted in a timely fashion so that the protocol approval does not lapse
• Assess educational needs of investigators and study staff; design training projects and conduct or facilitate individual and/or group training sessions
• Quality assurance visits are completed according to the protocol
• All local regulatory requirements are met and required assurances and approvals are in place
• Develop, monitor, and report on study budgets
• Assist with audit preparation as necessary
• Present reports defining project progress, problems, and solutions
• Responsible for research phlebotomy, sample process and storage, and sample shipments to the core lab for the study.
• Performs miscellaneous job-related duties as assigned

A minimum of 3 to 5 years of clinical research experience interacting with patients and the medical system as related to the duties and responsibilities specified. Experience with IRB administration and data management is required.

Bachelor's degree required; master's degree preferred.

• Excellent interpersonal and management skills with facility to interact professionally at all levels and plan and initiate new activities.
• Ability to design, prepare, deliver, and evaluate SOPs, source documents and other documents.
• Ability to compile and manage data, analyze information, and produce reports.
• Clinical knowledge as required for patient interviews and chart reviews.
• Knowledge and experience with human subjects research and IRB requirements.
• Administrative skills to meet the regulatory compliance required by IRB reporting.
• Excellent written and verbal communication skills.
• High level time management skills requiring exceptional organizational skills and the ability to organize time and prioritize effectively. This includes the ability to ask for direction when appropriate and the flexibility to handle multiple tasks and deadline pressures.
• Experience with common PC computer software including Microsoft Word, PowerPoint, Excel, Outlook, and reference management software such as Reference Manager or EndNote.
• Facility with learning new computer applications.
• Perform literature searches using PubMed and other search engines and perform Internet searches using MS Internet Explorer and various search engines.
• Good proofreading skills.
• Ability to compile and manage data, analyze information, and produce reports.
• Assist with materials management, supply, inventory, and ordering of program materials.
• Excellent critical thinking skills and ability to work independently are essential
• Must be self-motivated, and highly resourceful
• Excellent verbal and written communication skills
• Excellent discretion and judgment with the ability to problem solve independently, and knowing when to escalate to leadership
• Flexibility and organizational skills in a fast-paced, complex environment
• Ability to navigate within a complex organization, e.g. to understand fit with organizational goals/priorities, build consensus, facilitate decision-making
• Ability to maintain the utmost confidentiality of sensitive and personal information
• Strong computer skills--Proficiency in Word, PowerPoint, Excel--are essential
• Ability to develop templates, organize technical information, and maintain functional schedules
• Ability to educate and conduct training sessions both on individual and group levels
• Knowledge of and compliance with all hospital, State, and Federal regulatory requirements, including hospital policy and procedures, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Comfort interacting and communicating effectively with high-level hospital administration, physicians, Principal Investigators, all levels of hospital staff, external funding agencies, and maintain a variety of internal and external contacts

Duties will be performed in a research laboratory, research office, outpatient clinic, operating room, ICU and patient floors. May be exposed to blood products, sharp instruments such as needles, and cleaning supplies. Will require walking and occasionally lifting medium objects.

Evening hours will be needed to follow-up with study participants by phone and/or meet with staff. You may be required to attend and travel to meetings and trainings outside of regularly scheduled hours. Occasional weekend hours may be needed.

Will participate in the training, orientation and education of research staff, interns, and volunteers.

With the help of a Grant Manager, the incumbent will be responsible for developing, monitoring, and providing regular updates to the PI and the Program Manager on numerous study budgets. The Project Manager will be responsible for the purchasing of study-related equipment and supplies as needed. The Project Manager will be expected to aid in the search for and application to various internal and external funding opportunities, including grants and philanthropic gifts.