Biospecimen Regulatory Coordinator

Posted 3 Days Ago
Be an Early Applicant
Service, MS, USA
In-Office
67K-102K Annually
Senior level
Healthtech • Biotech
The Role
Oversee biospecimen regulatory compliance and governance for cancer research. Review protocols, consent forms, agreements, and related documentation; develop governance plans, policies, manuals, and procedures; coordinate biospecimen transfers; facilitate review committees; monitor utilization and compliance metrics; train researchers and staff; and support biospecimen projects, workflows, and process improvements.
Summary Generated by Built In
Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer.As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 11,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work For in the Nation and is continually named one of the Tampa Bay Times’ Top Workplaces.

Summary


Biospecimen Regulatory Coordinator


Help advance groundbreaking cancer research through regulatory excellence and biospecimen governance. Join Moffitt Cancer Center and play a key role in supporting ethical, compliant, and innovative research initiatives that impact patients worldwide.


Position Highlights

The Biospecimen Regulatory Coordinator serves as the institutional resource for biospecimen regulatory oversight and governance. This position plays a critical role in ensuring regulatory compliance, supporting biospecimen-related research activities, facilitating governance processes, and collaborating with faculty, researchers, and institutional stakeholders to promote the ethical and compliant use of biospecimens in research.


The Ideal Candidate

·       Strong knowledge of research regulatory requirements, biospecimen governance, and research compliance practices.

·       Excellent organizational skills with the ability to manage multiple priorities and deadlines simultaneously.

·       Strong written and verbal communication skills and the ability to work effectively with multidisciplinary teams.

·       Experience interpreting regulatory requirements, developing procedures, and implementing process improvements.

·       The ability to work independently while serving as a trusted resource and collaborator throughout the institution.


Responsibilities

·       Serve as the subject matter expert for biospecimen regulatory compliance and governance activities.

·       Review protocols, consent forms, agreements, and related documentation to ensure compliance with institutional policies and regulatory requirements.

·       Develop, implement, and maintain biospecimen governance plans, laboratory manuals, policies, and procedures.

·       Coordinate biospecimen transfers and facilitate regulatory activities related to biospecimen use and distribution.

·       Lead and facilitate institutional biospecimen governance meetings and review committees.

·       Monitor and report biospecimen utilization metrics and compliance activities.

·       Provide education and training to researchers and staff regarding biospecimen governance policies and best practices.

·       Partner with faculty and research teams on biospecimen planning, onboarding, transfers, and research-related initiatives.

·       Utilize project management techniques to support complex biospecimen-related projects, workflows, and process improvements.


Minimum Qualifications

·       Bachelor's Degree in Biomedical Science or a related field is required with five (5) or more years of research regulatory and/or biospecimen experience coordinating multiple complex assignments; OR

·       Associate degree with seven (7) or more years of research regulatory and/or biospecimen experience coordinating multiple complex assignments.

Preferred Qualifications

·       Master's Degree in Science or a related field.

·       Clinical research certification (CCRA, CCRC, CCRP, CIP, CIM, or similar).

·       Experience with biospecimen research operations and regulatory oversight.

·       Experience using reporting, analytics, or visualization tools such as R, SQL, Python, SAS, Tableau, Power BI, or similar applications.


Moffitt Team Members are eligible for Medical, Dental, Vision, Paid Time Off, Retirement, Parental Leave and more. Tampa is a thriving metropolitan city, which has become a hub for ground-breaking research, welcoming individuals from around the globe. This diverse city is engulfed with rich culture, year-round activities, amazing cuisine and so much more. We strive for work/life balance.


If you have the vision, passion, and dedication to contribute to our mission,

then we have a place for you.




Salary Range

$66,539.20 - $101,504.00

Salary ranges posted for this position represent the expected base pay range for the role. Actual compensation may vary based on location and a variety of job-related factors, including experience, skills, education, and internal equity among Team Members in similar positions.


We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.


Moffitt Career Site

 

 

If you have the vision, passion, and dedication to contribute to our mission,then we have a place for you!

1. Equal Employment Opportunity

Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.

2. Reasonable Accommodation

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Moffitt endeavors to make moffitt.org/careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact one of the Human Resources receptionists by phone at 813-745-7899 or by email at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Read more information about your EEO rights under the law. 

Transparency in Coverage Rule

Skills Required

  • Bachelor's degree in Biomedical Science or a related field
  • Five or more years of research regulatory and/or biospecimen experience coordinating multiple complex assignments
  • Associate degree with seven or more years of research regulatory and/or biospecimen experience coordinating multiple complex assignments
  • Master's degree in Science or a related field
  • Clinical research certification such as CCRA, CCRC, CCRP, CIP, CIM, or similar
  • Experience with biospecimen research operations and regulatory oversight
  • Experience using reporting, analytics, or visualization tools such as R, SQL, Python, SAS, Tableau, or Power BI
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The Company
11,000 Employees
Year Founded: 1986

What We Do

Moffitt Cancer Center is a Florida-based, NCI-designated comprehensive cancer center focused exclusively on cancer treatment, prevention, research, education and innovation. Its multidisciplinary clinicians and scientists work together to improve diagnosis, develop revolutionary breakthroughs, deliver individualized care and save more lives. Moffitt operates dedicated cancer hospitals and outpatient centers and serves patients while advancing oncology science through integrated clinical care and translational research.

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