RESEARCH REGULATORY PROJECT MANAGER / 40 HOURS / DAY / BWH - RESEARCH
GENERAL SUMMARY/OVERVIEW STATEMENT:
The mission of the Center for Clinical Investigation (CCI) is to strengthen the culture for clinical research at the Brigham and Womens Hospital, by
building services helpful to clinical investigators and facilitating the success of individual investigators. CCI is organized into 6 programs, each led by a
BWH faculty member.
The Regulatory Project Manager will work independently and report to the Senior Project Manager and/or Administrative Directors. The project manager will lead implementation of clinical research protocols as well as advice CCI staff and the BWH research community on clinical research regulations.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
The Project Manager will be responsible for providing independent judgment on regulatory and clinical research services within the CCI and the BWH Research
community as well as mentoring junior project managers and coordinators. The project manager will:
1. Independently coordinates and manages protocol submissions, as well as prepares and submits regulatory documents. Review and monitor progress of
clinical research studies. Prepares, leads, and participates in monitoring visits by sponsors. (~30%)
2. Provides advice on regulatory documentation including IND/IDE applications, annual reports, Serious Adverse Event reports, etc. to the appropriate
regulatory agencies including the U.S. Food and Drug Administration (FDA). (~20%)
3. Reviews and advices junior staff in regards to the maintenance of various regulatory records and databases with information related to study
recruitment, subject enrollment, and study completion. (~10%)
4. Responsible for making sure CCI protocol records are in regulatory compliance with Partners policies as well as federal and ICH/GCP guidelines.
Develops, implements, and documents standard procedures for managing studies supported by CCI. (~10%)
5. Trains more junior staff on regulatory process and procedures as well as becomes a resource for BWH coordinators and PIs. (~10%)
6. Meet regularly with Medical Director, Study Principal Investigators, and CCI Administration. (~10%)
7. Maintains up to date knowledge of local and federal regulations and guidelines (~6%)
8. Participate in ongoing training and educational activities within CCI including presenting relevant clinical research and regulatory issues. (~2%)
9. Coordinates and leads other CCI activities (~2%) including:
a. Planning, Budgeting and Feasibility consultations - Working in concert with Principal Investigator and/or Research Manager, develops budget estimates
and feasibility assessments.
b. Provides support for CCI program development.
c. Supports or leads marketing related activities.
10. All other duties, as assigned.
HOSPITAL WIDE RESPONSIBILITIES:
Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH/Partners, follows safe
practices required for the position, complies with appropriate BWH and Partners policies and procedures, fulfills any training required by BWH and/or
Partners, as appropriate, brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff.
1. Bachelors degree required.
2. At least 5 years of work experience in clinical research, preferably actively
coordinating human research trials. 1 year of regulatory compliance
experience (FDA, IRB etc) preferred.
1. Thorough knowledge and understanding of ICH/GCP guidelines and
2. Sound independent judgment
3. Excellent written and oral communication skills
4. Ability to analyze information and problem solve
5. Maintain confidentiality of information
6. Demonstrate good decision-making and judgment
7. Strong attention to detail and follow-through skills
8. Demonstrated organization and time management/prioritization skills with the
ability to work independently are required.
9. Ability to effectively train and mentor
Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race,
color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements,
genetic information, military service, or other protected status.
Brigham and Womens Hospital I CARE Standards
The I CARE Standards guide me in my interactions with patients, family members, visitors, colleagues, and neighbors in my workplace and surrounding community
to optimize the Brigham experience and help fulfill my role in our mission of providing seamless, high quality patient and family centered care.
C.I will Communicate my commitment to high quality performance
A.I will Appear and act as a professional
R.I will Respect all individuals
E.I will Extend myself