Orthopaedics Research Project Manager
Brigham & Women's Hospital(BWH)

Boston, Massachusetts

Posted in Health and Safety


Job Info


We seek an energetic, organized, and detail-oriented Project Manager with experience in the oversight of a busy clinical academic research group for the Department of Orthopaedic Surgery at The Brigham and Women's Hospital. Primarily, the Project Manager will be responsible for overseeing the administrative and operational components of ongoing projects including but not limited to coordinating IRB and regulatory approval for projects. The Project Manager will work under the general direction of the Sr. Research Administrator and Principal Investigator(s) of the Division of Arthroplasty.

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.

Principal Duties and Responsibilities:

  • Responsible for aspects of daily research operations of the arthroplasty group.
  • Works on projects, coordinate action items, take initiative using all available resources
  • Oversight of study staff and research trainees in conjunction with PI's, provide training for study personnel where appropriate.
  • Work closely with Department's administrative director of research onboarding staff and research trainees and ensuring research staff are compliant with departmental, institutional and sponsor mandates
  • Monitors study progress, ensuring deliverables are met
  • Addresses research issues as needed
  • In conjunction with Principal Investigator, coordinate the implementation, both internally and externally, of sponsored clinical research studies.
  • Participates in the development, submission and implementation of new research protocols including design, data collection systems and IRB approval.
  • Review and monitor progress of clinical research studies.
  • Works closely with the Department's administrative director of research to ensure research billings are processed in a timely manner.
  • Communicates regularly with the PI(s) about all aspects of the research trial, including operational and ad hoc meetings with PI and study staff regarding upcoming and ongoing projects.
  • Provide project timelines and updates on milestones, ensuring project deliverables are met and contributing to mitigation strategies when necessary.
  • Work in collaboration with research finance on developing project budgets and tracking research costs.
  • Understand and be able to source CPT codes and associated fees related to the conduct of clinical studies.
  • Ensure that knowledge about regulatory requirements is current by reading and attending local seminars related to policy and regulatory issues (FDA, NIH, IRB, etc.).
  • Ensure protocols and records are in regulatory compliance with MGB policies as well as federal and ICH/GCP guidelines, including the submission of amendments and annual reviews to the IRB and/or appropriate agency which may include the FDA.
  • Assist research assistants and research trainees with implementation of study procedures, maintenance of source documentation, and regulatory requirements.
  • Trial/study events, including adverse events, are monitored properly, and reported as defined in the protocol and in accordance with MGB and IRB research policies, and agency guidance as needed.
  • Prepares, leads, and participates in monitoring visits by sponsors.
  • Develops, implements, and documents standard procedures for managing studies.
  • Manage websites and recruitment media, updating for content as often as required.
  • Implement recruitment strategies and assist with issues as they arise.
  • Monitors, maintains, sets up any study equipment. Maintains inventory and orders supplies when necessary.
  • Develop and maintain systems and operating procedures to aid study management and operations.
  • Arrange meetings, conferences, seminars, travel for the program which may include external guests.
  • Assist with materials management, supply, inventory, and ordering of program material
  • Assists with preparation of manuscripts for publication and of abstracts and presentations for professional meetings
  • Responsible for the administrative oversight of the Department's MOTOR (Mentoring Orthopaedic Trainees in Orthopaedic Research) program


Qualifications
Qualifications:

Required:
  • Bachelor's degree required. Master's degree preferred
  • 5+ years of experience working in clinical research study management. Prior supervisory experience required.
  • At minimum, a 2 year commitment is required
Preferred:
  • Experience interacting with patients and the medical system as related to the duties and responsibilities specified.
  • Fluency with IRB administration, regulatory documentation, and data management.
  • Strong proficiency in Microsoft Office applications, agency forms (FDA, NIH, CDC, etc.), and management applications.
  • Prior supervisory experience.
Skills/ Abilities/ Competencies:
  • 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.
  • 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.
  • Strong computer skills and experience with common PC/Mac software including Microsoft Word, PowerPoint, Excel, Outlook, and reference management software such as Reference Manager or EndNote, EPIC.
  • 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.
  • Excellent critical thinking skills and ability to work independently are essential.
  • 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.
  • 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.
  • Ability to develop templates, organize technical information, and maintain functional schedules.
  • Ability to educate and conduct training sessions both on individual and group levels.
  • 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.


EEO Statement
BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.



More Health and Safety jobs


Compass Health Network
Columbia, Missouri
Posted about 6 hours ago

Compass Health Network
Wentzville, Missouri
Posted about 6 hours ago

NDX, LLC
De Pere, Wisconsin
Posted about 1 hour ago

Improve Job Search

Subscribe to job alerts and add your resume to our resume database for employers!


Sign up now


Share diversity job

Orthopaedics Research Project Manager is also posted to sites within our Diversity Job Network.


African American Job Search Logo
Asian Job Search Logo
Disabled Job Seekers Logo
Hispanic Job Exchange Logo
LGBT Job Search Logo
Seniors to Work Logo
US Diversity Job Search Logo
Veteran Job Center Logo