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Position: Clinical Research Coordinator/Regulatory Assistant

Location: Boston, MA

Schedule: 40 hours per week

ABOUT BMC:

At Boston Medical Center (BMC), our diverse staff works together for one goal - to provide exceptional and equitable care to improve the health of the people of Boston. Our bold vision to transform health care is powered by our respect for our patients and our commitment to ensure everyone who comes through our doors has a positive experience.

You'll find a supportive work environment at BMC, with rich opportunities throughout your career for training, development, and growth and where you'll have the tools you need to take charge of your own practice environment.

POSITION SUMMARY:

The CRC/Regulatory Assistant is responsible to ensure the maintenance of regulatory documentation for the portfolio of studies within the program. This person prepares and submits IRB continuing review reports, amendments, revisions, deviation reports, protocol exceptions, CAPAs, new information and unanticipated events and safety reports to local and central IRBs for Industry sponsored and NCI- sponsored clinical trials.

JOB RESPONSIBILITIES:

• Meeting Scheduling: pre-study visits, site selection and site initiation visits, monitoring visits and monthly sponsor updates
• Coordinates with representatives of pharmaceutical companies and/or CROs as required for site feasibility visits, site initiation visits, all monitoring/audit visits, and study close out visits for all studies.
• Carries out study preparation for investigator meetings, site training, tracking of these activities, and resolves queries raised by other study teams and CROs.
• Assists the Sr. Regulatory Manager to perform Quality Control checks in preparation for audits or site monitors for industry-sponsored protocols. Ensures that the CH-CRP office is "audit-ready" at all times, with regard to regulatory documentation

ADMINISTRATIVE

• Submits and maintains timely documentation for investigator research licenses along with submission of annual NCI Investigator renewal packets (RCR) to the FDA for each investigator.
• Maintain current certifications in Good Clinical Practice, the Protection of Human Subjects and HIPAA, CVs, IND research licenses
• Maintain basic regulatory documents across all studies within the Cancer & Hematology Clinical Research Program.
• Maintains regulatory binders with the above documents as well as IRB approvals and study-related correspondence for each protocol from pre-activation through close-out, making sure to update each document as information changes or the document expires.

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

EDUCATION:

• CRC I: Entry Level Position
  • Baccalaureate Degree Required AND 0-2 years experience

KNOWLEDGE AND SKILLS:

• Excellent organization and communications skills required.

• Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts.
• Must be detail oriented and have the ability to follow-through.
• Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times.
• Must have computer skills including the use of Microsoft Office Suite

JOB BENEFITS:

• Competitive pay
• Tuition reimbursement and tuition remission programs
• Highly subsidized medical, dental, and vision insurance options
• Career Advancement/Professional Development: Access a wealth of ongoing training and development opportunities that will not only enhance your skills but also expand your knowledge base especially for individuals pursuing careers in medicine or biomedical research.
• Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.

ABOUT THE DEPARTMENT:

As the primary teaching hospital for Boston University Chobanian & Avedisian School of Medicine and BU schools of public health and dentistry, intellectual rigor shapes our inquiries. Our research is led by a belief that skin color, zip code, and financial circumstances shouldn't dictate health.

Boston Medical Center is an Equal Opportunity/Affirmative Action you need accommodation for any part of the application process because of a medical condition or disability, please send an e-mail call617-638-8582to let us know the nature of your request.

Equal Opportunity Employer/Disabled/Veterans