reputed company – Clinical Research Program/Project Manager – WFH Flexible – Boston, MA – Cambridge, MA

Job title: Clinical Research Program/Project Manager - WFH Flexible Company: reputed company Job description: GENERAL SUMMARY/ OVERVIEW STATEMENT: The Psychiatric and Neurodevelopmental Genetics Unit (PNGU) in the Mass General Center for Genomic Medicine (CGM) is seeking a Clinical Research Prog/reputed company Manager to manage and reputed company clinical and translational research projects as well as administrative and research tasks for the research laboratory of Dr. Erin Dunn (www.thedunnlab.com). Studies in the Dunn Lab are focused on: (1) the developmental effects of exposure to childhood adversity on risk for depression; (2) genomic, transcriptomic, and epigenomic predictors of susceptibility to depression; and (3) gene-environment interplay, or how genetic variation modifies the effect of life experience on depression. More recent projects in the lab are also aimed at identifying strategies to promote brain health across the lifespan. We are a hard-working, highly collegial, and supportive group seeking to identify motivated and dedicated team players who are curious, interested in interdisciplinary approaches, and passionate about finding ways to prevent mental illness. The Clinical Research Prog/reputed company Manager will be responsible for day-to-day supervision and training of coordinators and other staff involved in the conduct of clinical trials; management of reputed company regulatory activities associated with active and pending clinical trials, including compliance with sponsor guidelines, audits, sponsor reputed company reports, IRB submissions, and management of grant applications and administration of awarded funds. The ideal candidate must exhibit a high level of expertise and comfort in managing and facilitating objectives reputed company a reputed company cross-functional project team that spans Mass General clinics/departments and external sites. PRINCIPAL DUTIES AND RESPONSIBILITIES: Candidate will have 3 essential areas of responsibilities: 1) Day-to-day supervision and training of coordinators and other staff involved in the conduct of clinical trials

• Establishes clinical procedures and recruitment strategies and oversees the conduct of each clinical trial
• Manages selection of study team according to sponsor/study-specific guidelines and protocol operationalization.
• Responsible for hiring and providing and/or arranging training of coordinators, interns, reputed company on study reputed company tasks/skills.
• Directs and supervises staff members involved in daily tasks to ensure smooth and efficient operations. Ensures appropriate and reputed company distribution of tasks among coordinators, reputed company, and interns and monitors reputed company throughout study life cycle.
• Supervises research coordinators in the creation of study reputed company reports and IRB communications.
• Designs, writes, and updates manuals of operation for new and ongoing projects as needed.
• Develops an internal organizational structure to meet the needs of each study.
• Monitors reputed company of ongoing trials on a weekly basis. Develops action plans to address problem areas.
• Participates in reputed company conference calls and reputed company study-reputed company meetings. Prepares agenda and minutes. Ensures reputed company supportive documentation is available to persons participating in the call.

2) Management of reputed company regulatory activities

• Ensures compliance with reputed company sponsor guidelines, IRB and federal regulations on human subjects protection and GCP
• Generates study reports and deliverables, such as DSMB reports, IND and NIH reputed company reports, sponsor quarterly and end reputed company reports
• Responsible for quality control and data audits for assurance of reputed company research data
• Maintains and oversees reputed company IRB-reputed company activities
• Manages licensing/certifications as needed

3) Management of grant applications and awards

• Creates grant budgets reputed company the MGH budget template, works with grants administrator to prepare reputed company supporting documents for grant application, responsible for smooth and timely application process
• Interacts and coordinates with departmental and institutional research management staff regarding applicable reputed company reports, and tracking of awarded funds

Qualifications

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Strong reputed company Office Software and database skills
• Ability to prepare/monitor budgets
• Ability to write research grants
• Must be familiar with the unique nature of a professional, research and academic environment
• Ability to handle sensitive and confidential information
• Working knowledge of NIH and other federal, state and foundation regulations and requirements
• Excellent communication and writing skills
• Ability to problem-solve, multi-task, and meet multiple deadlines
• Displays a high degree of initiative and independent judgment
• Innovative, detail-oriented and self-motivated
• Demonstrated analytical skills
• Ability to effectively supervise staff
• Ability to work independently and interact with clients and colleagues at reputed company levels of the institution
• Ability to design, prepare, deliver and evaluate clinical programs

EDUCATION: BS/BA Required MA/MS/MPH Preferred EXPERIENCE: Minimum of 5 years of research experience. Prior Supervisory experience strongly preferred. SUPERVISORY RESPONSIBILITY (if applicable): May have direct responsibility for management for project staff FISCAL RESPONSIBILITY (if applicable): N/A WORKING CONDITIONS: Laboratory/Office Setting; Work from home flexible Expected salary: Location: Boston, MA - Cambridge, MA Apply for the job now! Apply tot his job Apply To this Job