Manager, Research Operations

Astera Cancer Care; Nashville (TN); On-site; USD 90,000 - 140,000; Full time

Job summary

Tennessee Oncology, a leading community-based cancer care network based in Nashville, seeks a Clinical Research Regulatory Manager to oversee the Research Department's regulatory activities. You will guide CRCs, implement training programs, and ensure compliance with FDA/ICH guidelines.

Join a mission-driven team dedicated to high-quality cancer care and research across multiple community locations, with opportunities for professional development and impact.

Qualifications

• Bachelor's Degree or equivalent combination of education and experience required.
• Four years of relevant experience required.
• Certification in clinical research coordination from ACRP or SOCRA preferred.

Responsibilities

• Efficiently manages regulatory aspects of the Research Department.
• Provides leadership in development and implementation of regulatory strategies for clinical research missions.
• Stays up to date with new SOPs and regulations and aligns training accordingly.
• Serves as preceptor for new research staff members.
• Maintains regulatory documents according to policies and regulations.
• Liaises with sponsor staff and prepares for audits.

Skills

Verbal communication

Written communication

Organization

Follow-up

Multi-tasking

Trial protocols

Teamwork

MS Office

Bilingual EN/ES

Education

Bachelor's Degree

4 years experience

ACRP/SOCRA cert preferred

Tools

Microsoft Office

Job description

Tennessee Oncology, one of the nation’s largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology’s mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.

Why Join Us?

We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description:

Responsible for the efficient management of clinical trial coordinators (CRCs) of the Research Department. Provides in-depth knowledge, expertise, ongoing support, education, and training to CRCs regarding the conduct of clinical research studies. Guides CRC staff, setting and communicating priorities and performance standards. Stays up to date with new and revised standard operating procedures and regulations. Works with departmental leadership to align training and staff development, implementing new training programs to meet emerging/unmet needs.

ESSENTIAL FUNCTIONS:

• Efficiently manages all regulatory aspects of the Research Department.
• Provides expertise and leadership in the development, preparation, and implementation of regulatory strategies to support clinical research missions.
• Screen potential subjects for clinical trials through a careful review of the patient’s past medical history and a review of current findings against inclusion and exclusion criteria specific to a trial Obtain and maintains informed consents of each patient for the duration of a study Coordinate all patient visits including testing and procedures as per sponsor protocol Provides accurate and timely data collection, documentation, entry, and reporting in both sponsor and Tennessee Oncology databases while complying with sponsor protocol requirements, regulations, and department policies
• Communicates with principal investigator, outside physicians, regulatory staff, and sponsor regarding serious adverse events including proper documentation and follow-up.
• Serves as preceptor for new research staff members
• Maintains regulatory documents in accordance with department policies and regulations
• Liaises with sponsor staff such as study monitors and prepares, and attends monitor visits
• Prepares for and attends sponsor and FDA audits
• Procures, processes, and ships biospecimens per sponsor protocol and regulations.
• Protects the rights, safety, and welfare of patients
• Strives to maintain harmonious relationships with clinic personnel, administrative staff, patients, their caregivers, and the public
• Reviews newly activated protocols, amendments, notices, suspensions, and terminations.
• Responsible for maintaining current knowledge of the Code of Federal Regulations and International Council for Harmonization Guidelines
• Maintains required certification in Good Clinical Practice, Human Subjects Protections, and biological shipping training
• Serves as a liaison to multiple Tennessee Oncology departments, providers, and other personnel regarding research protocols and regulatory compliance
• Maintains a professional approach respecting the dignity and confidentiality of patients
• Maintains a good attendance record and reports to work on time
• Maintains a professional attitude and appearance
• Maintains Tennessee licensure as applicable
• Performs other duties as assigned

KNOWLEDGE, SKILLS & ABILITIES:

• Excellent verbal and written communication skills
• Excellent organization and follow-up skills
• Ability to handle multiple priorities in a fast-paced environment
• Ability to understand complex clinical trials protocols
• Ability to function in multi-functional teams
• Microsoft Office product knowledge (Word, Excel, PowerPoint, etc.)
• Bilingual (English/Spanish) a plus

EDUCATION & EXPERIENCE:

• Bachelor’s Degree or equivalent combination of education and experience required
• Four years of relevant experience required
• Certification in clinical research coordination from ACRP or SOCRA preferred

Thank you for your interest in Tennessee Oncology. People like yourself have helped us grow into one of the largest and most influential oncology practices in the country. Our front line heroes are beloved by our patients and their families. Caring for cancer patients is a privilege.