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CLINICAL RESEARCH NURSE – (CRN)

DEPARTMENT NAME: Clinical Research Unit

PURPOSE OF THE JOB :

The Clinical Research Nurse/Associate is responsible for planning and conducting clinical research studies. The CRN/CRNA works closely with the study team to ensure clinical trials are conducted in accordance to protocols, standard operations procedures, Good Clinical Practise (GCP) and relevant regulatory requirements. The CRN/CRNA must maintain professional nursing standards to ensure quality clinical care during conduct of clinical trials. The CRN/CRNA will assume the role of a Protocol Leader or Protocol Leader Assistant as assigned.

CORE JOB TASK

Protocol Knowledge

• Demonstrates thorough knowledge and understanding of protocols.
• Liaises with the study team to ensure adherence of protocol requirements. Participates in the review of draft protocols.

Subject Recruitment

• Liaises with the study team and CRUTL for subject recruitment activities in accordance to study timelines.
• Participates in recruitment activities via approved media, flyers and brochures. Identify and source for appropriate sites or avenues for subject recruitment.
• Selects and recruits volunteers from query utility in existing database system.
• Ensures that recruitment/screening activities are in compliance with ICH-GCP (Good Clinical Practice), global and local SOP and guidelines, Singapore GCP and regulatory requirements.
• Conducts and coordinates all general screening activities such as screening laboratory tests, clinical procedures and data documentation.
• Hand-over subject Master Folders to Protocol Leader or designee prior to study commencement.

Study Conduct

• Responsible for organising and managing the protocol set-up activities which involves the development of appropriate forms, labels, set-up medical equipment and arranging pre-study meetings.
• Ensures that the clinical trial is conducted with a high standard of quality and safety in accordance with protocol, standard operating procedures, Good Clinical Practice and regulatory requirements.
• Leads or participates in study entry visit activities including assignment of subject numbers.
• Participates in clinical trial procedure/tasks as delegated by the Principal investigator or designee.
• Involves or assist in the administration of clinical trial material.
• Collects and verifies clinical trial data.
• Liaises with Clinical Research Technician in samples process management.
• Ensures proper storage of clinical trial data.
• Operates biomedical equipment during the conduct of clinical trials (eg YSI, Infusion Pump).
• Ensures the safety of subjects through the strict adherence to procedures stated in the clinical trial protocol such as adverse event reporting, dosing requirements and precision, subject follow up
• Coordinates with relevant personnel on other necessary auxiliary support e.g. subject’s diet and maintenance of the study areas.

Data Management and Quality Control

• Responsible for entry and verification of data in paper/electronic case record form, site data collection forms or other databases.
• Ensures the data management processes are carried out according to protocol, standard operating procedures and Good Clinical Practice.
• Maintaining close liaison with data management team and appropriate personnel for the development of the case record form and other data management activities.

Regulatory Compliance, Development and Training

• Demonstrates understanding and adheres to Good Clinical Practice, global and local policies and procedures and relevant regulatory requirements.
• Accountable for compliance of individual training requirements e.g. attends and acquires course credits as specified on the curriculum map.
• Ensures proper asset protection.

People

• Maintains good interpersonal relationship with colleagues.
• Exercises good Customer/Public Relation skills e.g.: good telephone etiquette and telemarketing skills.
• Demonstrates professional and clinical excellence in the care and management of clinical trial subjects; respect subject’s rights and privacy and keeps in strictest confidence all privileged information (PI).
• Orientates and assumes the mentor role for new staff where appropriate. Actively participates in individual performance management plan and yearly performance and developmental planning to support corporate priorities and business goals.

Technical Skills

• Demonstrates understanding of study procedures and performs study procedures in accordance with protocol requirements.
• Complies with Universal Precaution practises.
• Performs additional tasks and responsibilities as assigned.

Miscellaneous

• Carries out additional unit functions and responsibilities as needed by the unit (e.g. checking equipment, Subject Matter Expert for biomedical equipments and Global Medical Quality System, Consumables Officer, Safety Officer, etc).
• Familiar with Computer System Quality policies, procedures. Involves in the development and review of documents for equipment validation, standard operating procedures and processes as assigned.
• Performs additional tasks and responsibilities as assigned.

Supplementary Job Description* (only if assigned)

People*

• Supervises, coaches and manages the team members to effectively deliver the needs of the business.
• Conducts performance review with supervised team members and defines objectives in alignment with company objectives.
• Gives constructive feedback during the review to help staff identify their potentials/weakness and reviews projected plan on their personal growth and development.
• Plans, executes, conducts and supervises the training of agency nurses and other contract staff.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• Registered with Singapore Nursing Board.

REQUIRED SKILLS

• Strong communication and customer relation skills.
• Pleasant disposition, meticulous and systematic.
• Able to multi-task and perform under pressure of strict timelines.
• Computer literate.

OTHER INFORMATION

• Not Applicable

SENIOR CLINICAL RESEARCH NURSE (SCRN)

DEPARTMENT NAME: Clinical Research Unit

PURPOSE OF THE JOB :

The Senior Clinical Research Nurse is responsible for the operational functioning of clinical trials conducted in the CRU. The SCRN ensures clinical trials are conducted in accordance to protocols, standard operating procedures, Good Clinical Practise (GCP) and relevant regulatory requirements. The SCRN is responsible for supervising, including administering performance management, and supporting team members.

CORE JOB TASK

People Management

• Supervises, coaches and manages the team members to effectively deliver the needs of the business.
• Conducts performance reviews with supervised team members and defines objectives in alignment with company objectives.
• Gives constructive feedback during the review to help staff identify their potentials/weakness and reviews projected plan on their personal growth and development.
• Plans, executes, conducts and supervises the training of agency nurses and other contract staff.

Protocol Knowledge

• Demonstrates thorough knowledge and understanding of all protocols assigned to the team.
• Reviews and comments on draft protocols when applicable.

Study Conduct

• Responsible for the smooth running of team protocols on study days overseeing and guiding the operational ward performance.
• Ensures operational assignments are carried out according to processes and SOPs as applicable.
• Ensures professional nursing standards are practised and maintained for the safety of subjects (dosing precision, adverse event reporting etc).
• May assume the role of a protocol leader as necessary and when assigned.

Data Management and Quality Control

• Assists in entry/correction of data in paper and/or electronic case record/report form and database if needed.
• Ensures the data management and quality control processes are carried out according to protocol, standard operation procedures and Good Clinical Practice.

Regulatory Compliance

• Ensures CRU staff adheres to Good Clinical Practice Guidelines, global and local policies and procedures.
• Applies standard safety precautions to protect self and others from biohazard materials including blood borne pathogens.
• Ensures compliance to individual training requirements as well as that of team members.
• Ensures good documentation practices are met and all CRU staff are appropriately trained for their role.

Miscellaneous

• Familiar with Computer System Quality policies, procedures. Involve in the development and review of documents for equipment validation, standard operating procedures and processes as assigned.
• Performs additional tasks and responsibilities as assigned.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• Registered with Singapore Nursing Board.
• At least 3-5 years of nursing experience preferred.
• Prior experience in clinical research.

REQUIRED SKILLS

• Good leadership skills.
• Strong communication skills.
• People management skills.
• Computer literate.

OTHER INFORMATION

• Not applicable.

PHARMACIST

DEPARTMENT NAME : Clinical Research Unit

PURPOSE OF THE JOB :

Responsible for ensuring proper investigational product management and pharmacy services operation in Lilly-NUS (LNUS). Ensure compliance to local regulatory requirement, Lilly policy and procedures for all pharmacy services. Provides training and oversight to locum pharmacists as needed.

CORE JOB TASK

Pharmacy Services Operation

• Ensures proper investigational product (IP) management which includes sourcing, receipt, storage, preparation, dispensing, labelling, inventory accountability, reconciliation, retention, destruction and documentation etc.
• Ensures proper management of non-IP and auxiliary supplies.
• Ensures proper management of Special Security Substances (SSS), Controlled Drugs and Psychotropic drugs.
• Performs extemporaneous preparation (EP), aseptic compounding and other dispensing activities.
• Ensures proper management of randomization and unblinding procedures for blinded clinical trials.
• Assists the CRU technicians in ensuring the pharmacy equipment are maintained according to LNUS SOP and vendor’s recommendation.
• Liaises with external vendors for sourcing of IP, Non-IP and auxiliary supplies when required.

Protocol Review and Study Conduct

• Reviews and provides feedback during protocol development where applicable.
• Responsible to ensure pharmacy operations assigned are carried out according to the protocol and applicable procedure requirements throughout the clinical conduct of a study.
• Practices and upholds professional pharmacy standards on investigational product management to ensure safety of subjects/patients.
• Acts as pharmacy liaison for an assigned trial for the study team.

Regulatory Compliance

• Ensures compliance to Singapore Guideline for Good Clinical Practice (GCP), Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) and other applicable regulatory requirements.
• Ensures compliance to global and local policies and procedures.
• Ensures compliance to Extemporaneous Preparation Quality Agreement and applicable GMP standards.
• Reviews and updates Pharmacy local standard operation procedures as appropriate.
• Participates in applicable audit and inspection visits by Lilly and external agencies and ensures follow-up to issues takes place.
• May hold relevant licenses e.g. Form A license for poisons and psychotropic import license when required.

Technical Expertise

• Provides coaching to Locum Pharmacists as needed on IP management and aseptic compounding.
• Authorized personnel for SSS.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• Singapore Registered Pharmacist.
• Previous Hospital Pharmacy Experience (preferred).
• Experience in compounding (preferred).

REQUIRED SKILLS

• Clear communication skills.
• Meticulous and detail-orientated.
• Experience in compounding (preferred).
• General GMP knowledge (preferred).

OTHER INFORMATION

• Must be flexible with work hours to facilitate clinical trial material dispending which occurs predominantly in the early morning.