Research Assistant

Research Assistant

Permanent Full Time (40 Hours per Week)

Position Purpose

The purpose of this role is to assist the SCTL / Study Coordinators (SC) / Associate Study Coordinators (ASC) to plan, coordinate and administer clinical trials.

Responsibilities

Assists SCTL / SC / ASC oversee the planning, scheduling, and conducting of day-to-day activities and procedures, ensuring timely and efficient workflow.

Ensures that all assigned activities are conducted in accordance with the study protocol and standards and in compliance with all applicable laws, regulations, guidelines (ICH / GCP), NZCR policies, and NZCR Standard Operating Procedures (SOP's).

Assists SCTL / SC / ASC in recruitment of study subjects and manages subjects during screening and admission.

Assists SCTL / SC / ASC serve as primary point of liaison and coordination between investigators, NZCR staff, research participants, sponsors, and Ethics committees.

Assesses operational and material requirements for studies.

Resolves any problems that may arise to ensure that the quality of data collected is of a high standard.

Participates in initiation (SIV) and other study related meetings as required.

If required, accurately transcribes source data from subject workbooks to electronic case report forms (eCRF).

Reviews and in collaboration with the SC organise resolution of EDC queries.

Consults with local / central lab for lab data issues including requesting copies of missing lab reports.

Communicating inconsistencies in lab data reporting.

Performs miscellaneous job-related duties as assigned by SCTL / RM.

Reception covers as required.

Rotation as applicable.

Quality

Maintain compliance with all New Zealand Clinical Research standards, protocols, and regulatory requirements, adhering to Good Clinical Practice (GCP).

Regularly evaluates, documents, and refines clinical and operational processes to enhance accuracy, consistency, and overall quality.

Assists in training employees in quality standards, policies, and procedures, ensuring all team members understand and implement best practices.

Ensures accuracy, consistency, and currency in all research documentation and reporting, including accurate record-keeping, version control and timely updates.

Workplace Health and Safety

Champions a culture of health and safety, ensuring preventative measures are in place to minimize risk to team members and participants.

Actively identify and report health and safety hazards, accidents, incidents, injuries, and property damage.

Understands and complies with NZCR's Health and Safety policies and procedures.

Maintains adherence to all safety standards and processes.

Commits to personal health and safety at work.

General

Undertaking any other appropriate duties that may be required.

Minimum Position Qualifications

Education

Tertiary degree in a science-based discipline or planning / working towards such a degree.

Experience

Work or academic experience that shows the requirement for diligence and scientific understanding.

Knowledge, Skills & Experience

Essential : Meticulous diligence

Good knowledge of science and medical terminology

Ability to foster a cooperative work environment.

Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Ability and desire to seek, respond to and provide critique for continuous improvement of self and colleagues.

Skill in the use of a networked computer and Microsoft office applications.

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