The Department
Biomedical Research
ClinicalResearchRegulatoryCoordinator
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Regulatory Coordinator at The Department. Skills: Regulatory compliance, Clinical trial regulatory coordination, GCP and ICH guidelines, FDA regulations. Coordinate all aspects of initial protocol submissions, IRB amendments. Prepare and submit regulatory documents”
What You'll Achieve.
Ensure regulatory compliance with BMCU policies as well as federal regulation and ICH/GCP guidelines; Ensure established benchmarks are met for study start-up progress; Ensure all start-up activities are completed; Ensure various regulatory reporting required are Study Sponsor, FDA, IRB etc.; Ensure all required information is relayed
Industry & Context.
Good decision-making and judgment
What They're Looking For.
Must Have
Bachelor's degree (BA, BS) in life sciences, nursing, or other related discipline, Good Clinical Practices (GCP) Certificate, Human Subject Protection (HSP) Certificate, 2-3 years of related research experience or research specific training and education, Fundamental knowledge of the conduct and regulatory management of industry and federally funded interventional clinical trials, Excellent written and oral communication skills, Maintain confidentiality of information, Demonstrate good decision-making and judgment, Attention to detail and follow-through skills, Demonstrated organization and time management/prioritization skills, Ability to work independently, Proficient in the use of computers, Microsoft applications and databases
What You'll Do.
Coordinate all aspects of initial protocol submissions
Prepare and submit regulatory documents
Maintain records in accordance with GCP principles
Ensure regulatory compliance with BMCU policies
and ICH/GCP guidelines
Proactive initiation and fulfillment of regulatory compliance within CHCRP
Prepare and submit all protocol applications
and informed consent documents for SRC and IRB review and approval
Prepare and submit regulatory documentation (IND/IDE applications
Serious Adverse Event reports)
and organize Regulatory files for each assigned study
Maintain various regulatory tracking databases
Assist in the preparation and coordination of assigned study monitoring and auditing visits
Track and manage assigned new protocol start-up
and monitor study start-up progress
Communicate and collaborate with clinical trial key stakeholders through the start-up process
Create and maintain tracking for all subsequent submissions
Ensure various regulatory reporting required are Study Sponsor
Establish and maintain regular communication with study team
applicable regulatory agencies/offices
Serve as facilitator for study team and sponsor with regard to study status information
critical safety issues
consent and IDB amendments
How You'll Work.
Team & Collaboration
Work independently and collaboratively with a variety of personnel at all levels; Collaborate with faculty and study team members of BMCU and other external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations; Work interactively with CHCRP clinical research staff, leadership, the Office for Human Research Studies (OHRS), BMC Clinical Trial Office, ancillary departments supporting CHCRP clinical trials; Assist study coordinator, Investigator, BMCU stakeholders, Industry Sponsors, and third party auditors; Communicate and collaborate with clinical trial key stakeholders through the start-up process; Establish and maintain regular communication with study team, study sponsor, applicable regulatory agencies / offices; Serve as facilitator for study team and sponsor
Communication Scope
Excellent written and oral communication skills
Process & Methodology
Track and manage assigned new protocol start-up, Initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met, Ensure all start-up activities are completed, Create and maintain tracking for all subsequent submissions
Full Job Description
**Position** : Clinical Research Regulatory Coordinator, Cancer & Hematology Clinical Research Program **Location** : Boston, MA **Schedule** : 40 hours per week **POSITION SUMMARY** : The RC coordinates all aspects of initial protocol submissions, IRB amendments, prepares and submits regulatory documents, and maintains records in accordance with GCP principles on assigned studies to ensure regulatory compliance with BMC/BU policies as well as federal regulation and ICH/GCP guidelines. This position will work both independently and collaboratively with a variety of personnel at all levels, including faculty and study team members of BMC/BU and other external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Contributing to a culture of compliance, the RC works interactively with CHCRP clinical research staff, leadership, the Office for Human Research Studies (OHRS), BMC Clinical Trial Office, ancillary departments supporting CHCRP clinical trials, and is responsible for the proactive initiation and fulfilment of regulatory compliance within CHCRP. **JOB RESPONSIBILITIES:** Regulatory Compliance * Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval. * Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), etc. * Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, BMC/BU sponsored etc. * Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion. * Assists in the preparation and coordination of assigned study monitoring and
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