Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Develop and execute comprehensive SOPs to ensure strict adherence to protocol requirements and maintain the highest standards of practice, while guaranteeing full compliance with Good Clinical Practice (GCP) standards.
- Formulate and implement robust training programs for the clinical team, thereby enhancing their understanding of compliance protocols and ethical considerations.
- Conduct meticulous audits and internal monitoring of selected research protocols to mitigate compliance discrepancies.
- Develop and deliver engaging training sessions that foster awareness and education regarding compliance protocols for the clinical team.
- Develop and implement streamlined processes to enhance operational efficiency and ensure timely reporting.
- Devise and implement a comprehensive regulatory compliance strategy for clinical trials across diverse therapeutic areas.
- Provide expert regulatory guidance on clinical trial protocol implementation and regulatory submissions.
- Anticipate and assess potential regulatory risks and develop effective risk mitigation strategies.
- Develop, implement, and continuously update a comprehensive regulatory compliance training program to ensure that staff remains current with the latest regulatory compliance requirements in clinical research.
- Conduct thorough compliance audits on select clinical trials and meticulously document regulatory compliance.
- Ensure that all clinical trials adhere to applicable regulatory requirements, including ICH GCP guidelines, FDA regulations, EMA guidelines, and other relevant international standards.
- Monitor changes in regulatory requirements and communicate their implications for ongoing and future clinical trials.
- Collaborate closely with Clinical Operations to ensure unwavering adherence to regulatory standards and best practices.
- Provide expert regulatory guidance and contribute to the development of essential clinical and regulatory documents (e.g., source documents, training manuals, clinical study forms, and metric reports).
- Remain current on global regulatory trends, guidance, and industry practices.
- Prepare professional communications, such as memos, emails, reports, and other formal correspondence.
- Write and edit a variety of documents, ranging from letters to comprehensive reports and instructional documents.
- Establish and maintain a well-organized filing system, encompassing both electronic and physical records.
- Create comprehensive NTFs and CAPAs to meticulously document critical information, decisions, and actions related to clinical trials, regulatory submissions, and other pertinent activities.
- Develop and implement CAPAs to address identified issues, deviations, and non-conformances, thereby ensuring compliance with regulatory requirements and company procedures.
- Maintain accurate and up-to-date records of NTFs and CAPAs, facilitating easy access and retrieval for future reference and audits.
- Assist the clinical team in research endeavours by facilitating the protocol approval process and maintaining meticulous documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
- Assume responsibility for study completion processes, including data lock, study closeout, reporting, and archiving of study files, ensuring the completeness and continuity of all study data. Conduct ongoing checks of clinical/translational data entered on case report forms (paper or electronic) or in reports and ensure archival of appropriate/required documentation.
- Support processes and monitor practices to ensure that regulatory documentation related to clinical trials complies with Institutional Review Board (IRB) policies, procedures, and regulations.
- Demonstrate comprehensive knowledge of the safety reporting requirements outlined in the study protocol, FDA regulations, and other relevant regulatory bodies.
- Complete and maintain regulatory documents for all study personnel, including curriculum vitae, licenses, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs.
- Compile and maintain comprehensive regulatory binders (paper or electronic).
- Complete submission applications and other required documentation and prepare protocol-specific forms for submission to the IRB and sponsoring entities.
- Prepare DOA, training logs, and other necessary items for site activation and throughout the study conduct.
- Schedule and coordinate staff and other meetings for training purposes.
- Address and submit any queries or clarifications from IRB organizations.
- Assist in compiling AE, SAE, and/or PD reports with the clinical trial team and submit to the IRB, as applicable.
Requirements:
- Bachelor's degree in life sciences, pharmacy, or a related field.
- 2-5 years of experience in Quality Assurance (QA)/Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on clinical trials.
- Demonstrated experience in leading regulatory strategy and submissions for clinical trials across multiple trials.
- In-depth knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
- Strong leadership skills with experience in managing and developing teams.
- Excellent communication, negotiation, and project management skills.
- Ability to work effectively in a fast-paced, cross-functional environment.
- Proven ability to manage multiple projects and meet deadlines.
- Please note that due to the immunocompromised nature of our patients, annual flu vaccinations are required.