Clinical Research Project Manager

Clinical Research Project Manager-(3293501)

Description

GENERAL SUMMARY / OVERVIEW STATEMENT :

We seek an organized and detail-oriented Project Manager with experience in the conduct of clinical research studies. The Project Manager will be responsible for assisting with the coordination of two direct-to-participant studies that span both Massachusetts General Hospital (MGH) and the Broad Institute. These studies leverage the Broad Institute’s Juniper platform to facilitate informed consent of participants, administer surveys, link to electronic health records, and to collect biospecimens.

The Project Manager in this role will work under the general direction of the Principal Investigator and the Program Director. The Project Manager will be responsible for IRB and regulatory approvals. The Project Manager will plan and implement study protocols, create standard operating procedures, collect, and manage study data, assist in study outreach and engagement 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.

The Project Manager will engage, recruit and enroll participants to the studies. They will be responsible for data entry and management. In addition, the Project Manager will develop and manage budgets and contracts; manage appropriate databases for tracking scientific, financial, and administrative information; develop best practices; create standard operating procedures (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 and community leaders. 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.

PRINCIPAL DUTIES AND RESPONSIBILITIES :

The Project Manager will act as a critical liaison between the MGH and the other three participating sites. The Project Manager will oversee the implementation of the protocol at the site and is responsible for oversight of all protocol functions and activities.

• 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 PCORI standards
• Works with physicians and lab members to screen participants for research study by reviewing participant data for eligibility; ensures participants referred meet study criteria
• Establish recruitment and engagement strategies and assure implementation and goal attainment on study
• Oversee collection and integrity of study data
• Serve as a project administrator, working on systems improvement, project development and establishment of project SOPs
• Research and clinical staff have successfully completed all required training and certifications and all staff follows GCP procedures
• The protocol is meeting recruitment and follow-up targets
• Research study SOPs are followed
• Adverse events and serious adverse events 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 application is in compliance
• 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
• Performs miscellaneous job-related duties as assigned, which may include tasks related to other clinical research projects.

Qualifications

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.

öExcellent interpersonal and management skills with facility to interact professionally at all levels and plan and initiate new activities.

öAbility to design, prepare, deliver, and evaluate SOPs, source documents and other documents.

öAbility to compile and manage data, analyze information, and produce reports.

öClinical knowledge as required for patient interviews and chart reviews.

öKnowledge and experience with human subjects research and IRB requirements.

öAdministrative skills to meet the regulatory compliance required by IRB reporting.

öExcellent written and verbal communication skills.

öHigh 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.

öExperience with common PC computer software including Microsoft Word, PowerPoint, Excel, Outlook, and reference management software such as Reference Manager or EndNote.

öFacility with learning new computer applications and software programming.

öPerform literature searches using PubMed and other search engines and perform Internet searches using MS Internet Explorer and various search engines.

öGood proofreading skills.

öAbility to compile and manage data, analyze information, and produce reports.

öAssist with materials management, supply, inventory, and ordering of program materials.

öExcellent critical thinking skills and ability to work independently are essential

öMust be self-motivated, and highly resourceful

öExcellent verbal and written communication skills

öExcellent discretion and judgment with the ability to problem solve independently, and knowing when to escalate to leadership

öFlexibility and organizational skills in a fast-paced, complex environment

öAbility to navigate within a complex organization, , build consensus, facilitate decision-making

öAbility to maintain the utmost confidentiality of sensitive and personal information

öStrong computer skills Proficiency in Word, PowerPoint, Excel are essential

öAbility to develop templates, organize technical information, and maintain functional schedules

öAbility to educate and conduct training sessions both on individual and group levels

öKnowledge 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)

öComfort 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 office but may also include local and national outreach and engagement.

You may be required to attend an event 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 Director on the study budget. The Project Manager will be responsible for the purchasing of study-related equipment and supplies as needed.

EEO StatementMassachusetts General Hospital is an EqualOpportunity Employer.By embracing diverse skills,perspectives and ideas, we choose to lead. Applications from protectedveterans and individuals with disabilities are strongly encouraged

Primary Location

MA-Boston-MGH Main Campus

Work Locations

MGH Main Campus55 Fruit StreetBoston02114

Research-Management

Organization

Massachusetts General Hospital(MGH)

Schedule

Full-timeStandard Hours : 40

Shift

Day Job

Employee Status

RegularRecruiting Department : MGH Cardiovascular Research Center

Job Posting

Jun 11, 2024