Regulatory Coordination/Quality Assurance Manager

Job Summary: The position reports directly to the Sr Project Manager and/or Project Director of a large global clinical study. This position has management responsibility for specific roles within a clinical study assigned to support the day-to-day operational project management of assigned trial(s). Does this position require Patient Care? NoEssential Functions Collaborating with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment. Safety management and reporting to FDA, Data and Safety Monitoring Boards, Medical Monitors, funding agencies and other regulatory bodies. Collecting, reviewing and approving of all required regulatory documents; and working to ensure the study Trial. Managing multi-center trials funded by NIH, Industry standards. Collaborate with grants management team to prepare progress reports. Provide safety management oversight for studies, in collaboration with study PI and safety boards.

Qualifications: Education Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred Can this role accept experience in lieu of a degree? NoLicenses and Credentials Experience Progressively more responsible experience in a research related field 3-5 years required and Prior Supervisory Experience 1-2 years preferred

Knowledge, Skills and Abilities: Strong organizational and communication skills. Demonstrated analytical skills. Effective problem solving skills. Ability to supervise and train staff effectively. Strong database management and computer skills. Must possess aptitude for budget management.

Skills/Abilities/Competencies Required: High level of time management and organizational skills. Confident presenting to large audiences. Excellent leadership, written and verbal communication skills. A solid understanding of clinical research methodology and regulations, including FDA, OHRP, and ICH guidelines and regulations related to the conduct of clinical research trials; and ability to advise study teams on how best to implement these regulations. Ability to identify problems and develop potential solutions. Excellent computer skills working with Microsoft Office. Team player who can work independently in an extremely fast-moving, deadline-driven environment, while balancing multiple tasks simultaneously. Ability to make independent, effective decisions. The ability to develop and manage positive relationships with sponsor representatives, study team members, and vendors. Ability to lead and mentor cross-functional teams. Licenses, Certifications, and/or Registrations Professional certification in clinical research, quality assurance, regulatory affairs, or a related field is preferred but not required.

Education: Minimum Required: Bachelor's degree in a scientific, healthcare, clinical research, regulatory, quality, or related discipline. Experience

Required: Minimum of three (3) years of working experience related to clinical research, academic research, quality assurance or similar environment required.

Preferred: 2+ years as a clinical research coordinator at an investigational site. Background/familiarity with biology or other scientific discipline is preferred, but not required.

Working Conditions: This position requires 2 days weekly onsite at MGH. The remaining 3 days can be onsite at the Assembly Row location or remote. Must have reliable access to internet. Occasionally, and at the discretion of the Director of QA, the Regulatory Coordinator may be required to be onsite for meetings, sponsor audits, or regulatory inspections. Advanced notice will be given. Will travel by public roads and air travel as needed. On occasion, the Regulatory Coordinator may be required to travel within the United States to audit investigational sites or vendors at the discretion of the Director of QA.Remote TypeHybridWork Location399 Revolution Drive Scheduled Weekly Hours40Employee Type RegularWork ShiftDay (United States of America) Pay Range$63,252.80 - $102,596.00/AnnualGrade7At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement: 1200 The General Hospital Corporation is an Equal Opportunity Employer. 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. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.