Regulatory Specialist Job at Katalyst Healthcares & Life Sciences, San Diego, CA

TmU4Y005dkRTbmVxTE0yL3RRVUhEWU54dHc9PQ==
  • Katalyst Healthcares & Life Sciences
  • San Diego, CA

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



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.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

Similar Jobs

Lowe's

Warehouse Part Time Days Job at Lowe's

**Your Impact at Lowe's**Receiver/Stocker associates help keep our stores running and provide access to the products our customers...  .../Stocker for Lowe's.**How We Support You**Whether you need a part-time position or a place to plant yourself and grow, Lowe's is ready... 

Extended Stay America Suites - St. Louis – Fenton

Hotel Assistant General Manager Job at Extended Stay America Suites - St. Louis – Fenton

As the Hotel Assistant General Manager, you will play a pivotal leadership role in ensuring the hotel's daily operations run seamlessly. With minimal supervision, you will exercise independent judgment to optimize operations while upholding our vision, mission, and values... 

LifeStance Health

Licensed Marriage and Family Therapist (LMFT) Job at LifeStance Health

 ...Licensed Mental Health Counselor - LMHC, Licensed Clinical Mental Health Counselor - LCMHC, or Licensed Marriage and Family Therapist - LMFT) Experienced treating adults, children, and adolescents with a variety of mental healthcare needs. Job DescriptionAs a... 

Two95 International Inc.

Technical Writer Job at Two95 International Inc.

 ...Title: Technical Writer Location: Roseville, CA Duration : 6+Months contract Rate : $Open Requirements Essential Job Functions: IT background required to create, compile, and deliver more complex system/software developmental documentation... 

Sunridge Management

Leasing Agent Job at Sunridge Management

POSITION: LEASING CONSULTANT REPORTS TO: MANAGER The purpose of this job description is to communicate the responsibilities and duties associated with the position of LEASING CONSULTANT. While the following information should be considered a comprehensive description...