Senior Regulatory Coordinator Clinical Research

4 weeks ago

Cerritos, United States Oncology Institute, Inc. Full time

Senior

Regulatory

Coordinator

Responsibilities:

Serve as the Regulatory Manager in the absence of the acting manager

Maintains research practices using Good Clinical Practice (GCP) guidelines.

Assists

with auditing trials (Review and Preparation)

Reviews and Submits Protocol Deviations and SAEs to IRB.

Works directly with monitor and completes requests.

Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.

Multi-task and prioritize effectively

Organize multiple projects for efficiency

Work efficiently and complete tasks with a high degree of accuracy

Review IRB Portals for new approvals.

File and maintain reg binder/e-Reg.

Review DocuSign Portal and e-File documents.

Prepare and complete the release of IND Safety reports for several trials.

Assist

in FDA and Sponsor Audits

Skills & Abilities:

Knowledgeable of FDA and QA audit processes.

Strong interpersonal communication skills to interact with others effectively and diplomatically.

Strong writte

n com

munication skills, ability to compose correspondence and

maintain

large file system.

Typing and computer

skill

/ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).

Education and Experience:

Four or more (4+)

year

s

experience

with regulatory document submission to central IRB for review, followed by document tracking and follow-up, with continuing review report and amendment submissions as needed.

Demonstrated experience with multi-study and multi-site clinical research activities.

Demonstrated knowledge and understanding of human research policies, regulations, procedures, and

standards as

according to HIPAA, IRB, FDA, ICH, and GCP guidelines.

Demonstrated knowledge of FDA and Sponsor regulatory requirements.

Bachelor’s Degree

p

referred

#J-18808-Ljbffr

  • Senior Regulatory Coordinator Clinical Research

    4 weeks ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Job DescriptionJob DescriptionFounded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem...

  • Senior Regulatory Coordinator Clinical Research

    6 days ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions,...

  • Clinical Research Regulatory Coordinator

    2 weeks ago

    Cerritos, United States The Oncology Institute Full time

    Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions,...

  • Clinical Research Regulatory Coordinator

    2 weeks ago

    Cerritos, United States Oncology Institute, Inc. Full time

    Regulatory Coordinator This is a fantastic opportunity to join a team of quality-oriented professionals focused on Clinical Research in Cerritos, CA. Responsibilities: Maintains research practices using Good Clinical Practice (GCP) guidelines. M aintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in...

  • Clinical Research Regulatory Coordinator

    1 month ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Job DescriptionJob DescriptionFounded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem...

  • Clinical Research Regulatory Coordinator

    1 day ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions,...

  • Clinical Research Regulatory Coordinator

    1 month ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions,...

  • Regulatory Coordinator

    4 weeks ago

    Cerritos, United States Medix Full time

    Responsibilities: Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Handle confidential material with judgement and discretion E-filing and sorting from DocuSign to Trial folders on...

  • Clinical Research Accounting Associate

    2 weeks ago

    Cerritos, United States The Oncology Institute Full time

    Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions,...

  • Clinical Research Accounting Associate

    2 weeks ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Job DescriptionJob DescriptionFounded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem...

  • Clinical Research Accounting Associate II

    4 days ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Job DescriptionJob DescriptionFounded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem...

  • Credentialing Coordinator

    6 days ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Job DescriptionJob DescriptionFounded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem...

  • LVN Clinical Admissions Coordinator

    1 month ago

    Cerritos, United States MCM & Associates LLC Full time

    Job DescriptionJob DescriptionWe are seeking a skilled Licensed Vocational Nurse (LVN) to join our Palliative Care program in Cerritos. This role is not for hospice but specifically focuses on providing coordinated care and support to our patients and their families. This is an excellent opportunity for someone with strong administrative skills and a passion...

  • Laboratory Pathology Authorization Coordinator

    4 days ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Job DescriptionJob DescriptionFounded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem...

  • LVN - Beverly Hills - OB/GYN Clinic

    4 days ago

    Cerritos, United States CEDARS-SINAI Full time

    Job Description Why work here? Beyond outstanding benefits, competitive salaries and health and dental insurance we take pride in hiring the best, most passionate employees. Our talented staff reflects the culturally and ethnically diverse community we serve. They are proof of our commitment to creating a dynamic, inclusive environment that fuels innovation...

  • Senior Marketing Manager

    7 days ago

    Cerritos, United States Golden Star Technology Full time

    Job Title: Senior Marketing Manager Location: Cerritos, CA Position Overview: At GST, we are looking for a skilled and seasoned Senior Marketing Manager to drive our marketing strategy, corporate branding, marketing sales initiatives, client events, and vendor relationships. This position places a strong emphasis on event planning, content development,...

  • Senior Marketing Manager

    1 month ago

    Cerritos, United States Golden Star Technology Full time

    Job DescriptionJob DescriptionJob Title: Senior Marketing ManagerLocation: Cerritos, CAPosition Overview:At GST, we are looking for a skilled and seasoned Senior Marketing Manager to drive our marketing strategy, corporate branding, marketing sales initiatives, client events, and vendor relationships. This position places a strong emphasis on event planning,...

  • Senior Marketing Manager

    1 month ago

    Cerritos, United States Golden Star Technology Full time

    Job Title: Senior Marketing Manager Location: Cerritos, CA Position Overview: At GST, we are looking for a skilled and seasoned Senior Marketing Manager to drive our marketing strategy, corporate branding, marketing sales initiatives, client events, and vendor relationships. This position places a strong emphasis on event planning, content development,...

  • Lactation Consultant RN

    7 days ago

    Cerritos, United States Kaiser Full time

    Job Summary: Collaborates with Education Consultants and managers to develop, design, deliver and evaluate/improve education strategies and special projects/programs based on clients departmental goals and needs, as well as organizational goals/objectives. Implements education programs and strategies and coordinates to meet regulatory program requirements...

  • New Patient Scheduling Coordinator

    4 days ago

    Cerritos, United States The Oncology Institute of Hope and Innovation Full time

    Founded in 2007, The Oncology Institute of Hope and Innovation (TOI) is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI is dedicated to offering cutting edge, evidence-based cancer care to a population of more than 1.7 million patients including clinical trials, stem cell transplants, transfusions,...