Clinical Research Regulatory Specialist Bone Marrow Transplant Job Aurora area,Colorado USA,Healthcare

Job Overview

The Clinical Research Regulatory Specialist is responsible for the management of clinical research protocol documents and activity from initial submission through study closure. The primary focus is on the development, submission, maintenance, filing and reporting of regulatory documents while achieving and maintaining compliance with all internal, external and federal policies and regulations that apply to research involving human subjects. Provides regulatory guidance and direction to all members of the research team at Children's Hospital Colorado to ensure compliance with all applicable policies, procedures and regulations.

We are looking for a motivated, highly organized, team-oriented person to join our Bone Marrow Transplant (BMT) Research Team here at Children's Hospital Colorado! The Center for Cancer and Blood Disorders at Children's Hospital Colorado has one of the best pediatric hematology, oncology (cancer care) and bone marrow transplant programs in the country.

We treat kids, adolescents and young adults from birth through mid-20s with cancer and non-malignant blood disorders. The BMT program is one of the most experienced pediatric bone marrow transplant programs in the country. Our team is the region's most experienced pediatric blood and marrow transplant and cellular therapy (BMT) program. We have performed more than 1,100 bone marrow transplants and have a growing cellular therapy program offering new, effective and less toxic therapies for a variety of diseases.

We're using it to pioneer treatments with the hope of eradicating childhood disease and changing pediatric medicine - giving all kids a chance at a healthier future.

Our extraordinary team at Children's Hospital Colorado is creating the future of child health, and we need top talent to do it. Join us!

Additional Information:

Department: CCHRI-CCBD Clinical

Hours:

40 hours/week

Shift: Monday - Friday, 8am-4:30pm. Work hours may vary based on the needs of the department.

* This is a hybrid position.

ESSENTIAL FUNCTIONS

Independently develops and submits Study Institutional Review Board (IRB) documents such as consent forms and protocols for initial submissions, protocol amendments, and continuing reviews.

Independently maintains appropriate study documentation including regulatory binders and enrollment logs.

Responsible for preparing, maintaining and updating regulatory binders for review by internal or external monitoring/auditing groups; available to auditors and monitors to discuss regulatory issues at each visit; able to explain internal regulatory processes and Standard Operating Procedures (SOPs) as needed.

Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements.

Assesses current departmental processes and SOPs; provides suggestions for improvement.

Enters protocol specific data into required IRB and Children's Hospital Colorado systems.

Assists research team members in assessing and optimizing departmental workflows.

Assists in training/mentoring new staff, providing constructive feedback to other team members as necessary.

Maintains understanding of the professional guidelines and code of ethics related to clinical research conduct, and maintains ability to summarize and clarify these for study teams.

Maintains study compliance with Institutional Review Board, CHCO and other policies.

Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies.

Communicates clearly and in a professional manner with study teams, sponsors and IRB including timely communication when revisions or changes have been approved.

Recognizes when others need to be included in conversations and escalates appropriately.

Works closely with sponsors and study teams on the preparation of regulatory documents and addressing relevant regulatory issues.

Regularly participates in departmental meetings to discuss the regulatory status of assigned protocols.

MINIMUM QUALIFICATIONS

Education: Bachelor's degree in a related field is required.
Experience: Minimum of three (3) years of related experience is required.
Equivalency: Minimum of seven (7) years of related experience may be considered in lieu of minimum requirements.
Direct regulatory experience preferred

Salary Information

Pay is dependent on applicant's relevant experience.

Annual Salary Range (Based on 40 hours worked per week): $66,083.89 to $99,125.84

Benefits Information

Here, you matter. As a Children's Hospital Colorado team member, you will receive a competitive pay and benefits package designed to take care of your needs that includes base pay, incentives, paid time off, medical/dental/vision insurance, company provided life and disability insurance, paid parental leave, 403b employer match (retirement savings), a robust wellness program, and access to professional development tools, including an education benefit to help you advance your career.

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