Job Details
Title: Clinical Research Manager
Company: The Side-Out Foundation
Location: Local or Remote
Position Overview:
The Clinical Research Manager at the Side-Out Foundation will manage clinical research projects focused on advancing research in metastatic breast cancer. This role involves coordinating research studies and registries, ensuring compliance with regulatory requirements, ensuring clinical studies are conducted according to protocol, managing relationships with research teams, and supporting the foundation’s mission to help people living with metastatic breast cancer see more tomorrows.
The ideal candidate will possess strong leadership skills, a passion for cancer research, and a commitment to advancing medical science for the benefit of patients and communities.
Key Responsibilities:
* Manage the implementation of clinical trials, ensuring adherence to protocols, ethical standards, and regulatory requirements.
* Develop and maintain relationships with external partners, including hospitals, research institutions, and regulatory agencies.
* Recruit, screen, and enroll eligible participants in clinical trials according to study protocols.
* Serve as the primary point of contact for patients participating in clinical studies, providing education on the trial process, informed consent, and answering any questions they may have.
* Ensure proper documentation of medical histories, informed consent, and other required records.
* Monitor patient progress throughout the study, including tracking adverse events and ensuring proper follow-up care.
* Collect, document, and manage clinical data according to protocol, ensuring accuracy and completeness.
* Develop regulatory documentation, including preparation and submission of Institutional Review Board (IRB) applications, patient consent forms, and other required filings.
* Maintain study files, databases, and case report forms, ensuring compliance with confidentiality standards and regulatory guidelines.
* Coordinate and communicate with the study team, physicians, sponsors, and other stakeholders to ensure smooth operation of trials.
* Ensure compliance with local, state, and federal regulations related to clinical trials, including Institutional Review Board (IRB) submissions and Good Clinical Practice (GCP) standards.
* Prepare and submit progress reports, research findings, and grant proposals to stakeholders, including the foundation’s leadership and funding organizations.
* Stay current with the latest advancements in cancer research, clinical trial methodologies, and regulatory changes.
* Represent the foundation at conferences, seminars, and other events to promote research initiatives and build collaborative networks.
Attend and participate in study meetings, training sessions, and continuing education as required.
Qualifications:
* Bachelor’s degree in Life Sciences, Clinical Research, Nursing, or related field (Master’s degree preferred).
* Minimum of 5 years of experience in clinical research, with at least 2 years in a management or leadership role.
* Certification in Clinical Research (e.g., ACRP or SOCRA) preferred.
* Strong understanding of clinical trial design, regulatory requirements, and data management.
* Proven experience managing decentralized, multi-site or large-scale clinical trials.
* Excellent organizational, communication, and interpersonal skills.
* Ability to work collaboratively in a dynamic, team-oriented environment.
* Detail-oriented with strong problem-solving abilities and the ability to manage multiple projects simultaneously.
* Passion for cancer research and a commitment to the Side-Out Foundation’s mission
Benefits:
* Competitive salary and benefits package
* Opportunities for professional development and continuing education
* Collaborative, mission-driven work environment
* Chance to make a meaningful impact in the fight against cancer
To apply for this position or to learn more, please contact rick.dunetz@side-out.org.
SOCRA Exp: 3/25/2025
