Regulatory Manager/Study Coordinator - Temporary

Fred Hutch; Cape Town; On-site; USD 40,000 - 55,000; Full time

Job summary

A leading cancer research center is seeking a Regulatory Affairs Coordinator to support ethics and regulatory activities for clinical trials. This role involves overseeing submissions to regulatory bodies, ensuring compliance with GCP standards, and facilitating communication among stakeholders. Ideal candidates will have extensive experience in regulatory affairs, strong communication skills, and a background in clinical trials. Join us in making a difference in cancer research and patient care.

Qualifications

• 5+ years’ experience in health and research sector.
• 2+ years dealing with regulatory and ethical issues.
• Knowledge of Good Clinical Practice.

Responsibilities

• Oversee local submissions to Ethics/Institutional Review Boards.
• Manage participant recruitment and retention.
• Ensure regulatory communications are maintained.

Skills

Regulatory Affairs

Communication

Teamwork

Analytical Thinking

Problem Solving

Education

Tertiary degree or equivalent diploma in a related field

Tools

MS Office

Job description

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The main purpose of this position is to support the regulatory affairs activities conducted for the CTAC or other protocols as needed and to provide support to the unit with regards to overall management of all ethics and other regulatory matters. To co-ordinate clinical trials.

Responsibilities

Regulatory Administration (20%)

• Oversee and co-ordinate all local submissions to Ethics/Institutional review board (IRB) and other regulatory bodies.
• Act as interface between research team, sponsors, study coordinators (SCO’s) and universities to ensure complete and proper communication within projects and between all stakeholders.
• Manage the dissemination of information between all relevant stakeholders and IRBs.
• Monitor and review approvals to facilitate timeous renewal.
• Liaise with collaborators with regard to the preparation and submission of reports (including Serious Adverse Events (SAE) reports) to Human Research Ethics Committees (REC’s) / Institutional Review Boards (IRBs)

Coordination of Regulatory Affairs (20%)

• Lead the regulatory aspect of the study startup plan.
• Maintain and manage an efficient document filing and management system, including archiving procedures.
• Oversee the maintenance of investigator files with all essential documents.

Maintenance of Regulatory Documents (10%)

• Act as pivotal point of contact and develop regulatory affairs communication network for all collaborative sites.
• Ensure that investigator’s statutory and other documentation such as malpractice insurance and registration with Health Professionals Council of South Africa (HPCSA) (where applicable) is current and on file.
• Ensure accurate record keeping and timeous reporting to regulatory authorities.
• Provide consultation regarding ethics and regulatory issues.
• Advise regarding ongoing ethics GCP and GCLP training where appropriate.
• Oversee the import and exportation of vaccine and biological substances as it pertains to:
  • Obtaining relevant permits from various authorities.
  • Communicating and ensuring that permit conditions are met.

Study Coordination (50%)

• Ensure that protocols are reviewed, and adequate training of staff is maintained.
• Attend SIV, SAV and other investigator meetings/trainings as required.
• Attend monitors/audit visits as required.
• Ensure all study essential documentation is filed and up to date.
• Ensure all necessary approval for the study are obtained, and regulatory communications are maintained.
• Manage the recruitment and retention of study participants.
• Ensure that data entry is completed as per sponsor requirements.
• Ensure all adverse events are reported timeously.
• Ensure that the protocol, GCP and SOP guidelines are complied with at all times.
• Provide regular feedback to the study sponsor and principal investigator.
• Ensure that consenting, enrolment and follow up schedules are followed.
• Ensure that all study documentation is available, and progress reports are timeously submitted.

Qualifications

MINIMUM QUALIFICATIONS:

• Grade 12 and Tertiary degree or equivalent diploma in a related field.
• Professional registration/License as appropriate to qualification
• At least 5 years’ experience in working in the health and research sector.
• At least 2 years’ experience in a similar position dealing with regulatory and ethical issues.
• Experience and working knowledge of current enabling legislation as related to health and research.
• Experience and working knowledge of Good Clinical Practice and the Protection of Human Participants in Research.
• Experience and working knowledge of clinical trials.
• At least 5 years’ experience in clinical trials.

PREFERRED QUALIFICATIONS:

• Communication, teamwork, people management, clinical research and quality management experience
• Knowledge of South Africa Clinical Research Regulations
• Ability to work independently using own initiative
• Lateral, analytical and systematic thinking
• Ability to provide solutions to problems
• MS Office Skills
• Flexibility to adapt to changing job demands as the research unit evolves and develops
• GCP Standards
• Teamwork/collaboration
• Work management/Planning and organizing
• Problem solving/Analytical thinking
• Building interpersonal relationships
• People Management
• Quality commitment/Work standards
• Communication
• Client service and support
• Meeting facilitation/leadership, participation
• Research skills

Protection of Personal Information Act (POPIA) Consent to Use and Collection of Personal Information, Including Consent to Background Check.