• Job Description

  Req#: 1128488
  !*!
  GENERAL SUMMARY/ OVERVIEW STATEMENT:
  The Mucosal Immunology and Biology Research Center is looking for a Clinical Research Program/Project Manager who works independently and oversees a portfolio of clinical research projects/trials in the Yonker Lab. The Yonker Lab initiated a biorepository to collect specimens from pediatric patients, including those testing positive for COVID-19. Now we are focusing our efforts to understand post-COVID-19 complications in children, including Long COVID. The PM will plan and implement study procedures, coordinate the screening and recruitment of study patients, complete and administer regulatory paperwork, maintains study data and manages the day-to-day activities of the Pediatric VODI-19 biorepository. The PM may also participate in clinical trial grant development, submission, coordination, and implementation related to pediatric COVID-19 conditions.
  The PM will also oversee clinical research staff and operations to ensure quality in research procedures, job competency, regulatory compliance, and effective relationship management with sponsors/collaborators. The PM will provide leadership in the development, implementation, evaluation and revision of protocols, ensuring efficiency, safety and productivity.
  PRINCIPAL DUTIES AND RESPONSIBILITIES:
  Clinical Trial Oversight & Administration - Coordinates and oversees the implementation and activities of various clinical research protocols, including:
  • Prepare and submit protocols for IRB review;
  • Manage various project related tasks to ensure timely completion of the project;
  • Manage communications and meetings between various internal and external compliance regulatory groups;
  • Collaborate with other research staff: this includes site visits and regulatory management
  • May assist with providing basic explanation of study and obtaining informed consent from patients;
  • In conjunction with the clinical staff, screen for potential patients;
  • Ensure that adverse events (AE/SAE) are monitored properly and reported to the sponsor, federal regulatory authorities, and IRB;
  • Contributes to protocol recommendations and communicates these with the PI
  • Prepare and submit amendments to protocols, based on requests and suggestions by the P.I.;
  • Ensure study related regulatory documents are properly maintained;
  • Facilitate integration of regulatory issues to ensure safe practice;
  • Oversee clinical research trials: Act as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA, etc.), and other research staff to ensure adherence to the protocol;
  • Coordinate the implementation of research protocols ensuring data validation, regulatory compliance, and quality control;
  • Provide clinical research expertise and problem solving to address programmatic situations;
  • Assume additional administrative and clinical research tasks, as needed.
  Laboratory Leadership – In collaboration with the Director, manage the clinical research program operations and administration, including.
  • Supervise daily operations and staff, ensuring the needs of the study are met and staff perform to the requirements of the studies. Communicate and hold staff accountable to departmental and organizational procedures and policies, including safe practices;
  • Promote collaboration and a work environment conducive to teamwork and employee satisfaction;
  • Provide training and mentoring to clinical research staff to develop and ensure job competency; provide feedback and evaluate job performance. Support employees in job development, including certification.
  • Lead the recruitment of staff to include the screening, interviewing and selection of team members. Ensures staffing supports clinical trial needs.
  • Provide recommendations to PI to ensure maximum productivity and efficiency, such as educational and support services required for staff to perform their job and/or recommendations regarding resources needed for new studies;
  • Develop, implement and support systems to promote efficiency and productivity, standard operating procedure, IRB renewals, new studies and economy of resources.
  • Establish and maintain research files in accordance with current regulations. Develop tools, forms and processes regarding specific protocols to support the study and to ensure that staff members utilize these to facilitate tasks and operations.
  • Oversee the collection, recording and management of study data, including tracking, record keeping and reporting.
  !*!
  • Bachelor’s degree required;
  • 3-5 years of clinical research experience required
  • Some supervisory experience
  SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
  • Demonstrated knowledge of principles, SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance
  • Demonstrated ability to manage all aspects of clinical research study
  • Experience with medical chart reviews and electronic medical records;
  • Maintain current CITI/human subject research certifications
  • Excellent organizational, planning and time management skills with the ability to prioritize effectively and handle multiple tasks and deadline pressures.
  • Good judgment and problem-solving skills, ability to effectively coordinate people and schedules;
  • Ability to analyze complex situations and implement problem solving skills
  • Extraordinary attention to detail, ability to work carefully and efficiently with minimal supervision;
  • Demonstrated leadership and supervisory ability; able to delegate and prioritize for self and others; ability to inspire other team members
  • Ability to work both independently and as part of a busy, multidisciplinary team, interacting with diverse individuals at multiple levels within the research and clinical group;
  • Ability to demonstrate professionalism, interpersonal skills, compassion and respect for study participants’ rights and needs
  • Excellent oral and written communication skills
  • Ability and willingness to learn new research and administrative skills;
  • Initiative, interest and enthusiasm for change and willingness to take on new challenges
  • High level of proficiency with Microsoft Excel, Word, PowerPoint and computer data entry skills required;
  • Work hour flexibility and some intermittent work after normal business hours
  !*!
  Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
  
  MGH Main Campus (MGHMAIN)
  55 Fruit Street
  Boston, 02114
  
  MGH 529 Main (MGHCharlestown529Main)
  529 Main Street
  Charlestown, 02129
  
  

• About the company

  Mass General Brigham is a Boston-based non-profit hospital and physicians network that includes Brigham and Women's Hospital and Massachusetts General Hospital, two of the nation's most prestigious teaching institutions.

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