Clinical Research and You

Give people better opportunities to access new medicines and therapies. Become part of the greater Australian and New Zealand Clinical Research Network

How do we give people a better chance of living longer, staying healthy for as long as possible and living life to the full?

Since research started in the age of enlightenment to the present technological age, we have doubled our life expectancy. In 1841, a 5-year old could expect to live 55 years. Today, a 5-year old should live to 82.

Providing access to new medicines and medical procedures along with greater awareness of lifestyle choices empowers people to make informed decisions that deliver better health expectancies.

Professional

Designing and managing research projects.

Igniting the conversations between the client, specialist and patient.

Getting all the information we can find to help the fight.

We're dedicated to good clinical research practice that ensures the safety and care of our patients and the efficacy of therapies.

Clinical Research people
  • Clinical Trial Assistant (CTA)
  • Clinical Research  Associate (CRA)
  • Senior Clinical Research Associate (SCRA)
  • Regulatory Associate
  • Senior Regulatory Associate
  • Project Coordinator / Lead
  • Director Project Management
  • Director Clinical Operations
  • Director Quality Assurance
  • Managing Director


Specialist
  • Bridging the gap between patient and community.
  • Informing society about better ways to improve the health and care of patients.
  • Replacing fear and stigma with understanding about disease.
  • Keeping up to date with new and better ways to treat and care for patients.
  • Supporting patients during care.
Specialist Research people and places

Therapeutic Experts
Study Nurse
Study Coordinators
Principle and Sub Investigators
General Practitioner
Local Health and speciality clinics
Hospitals

Participant / Patient

Respecting everyday people from all walks of life, culture and belief who have personal and or altruistic reasons for becoming a participant in a clinical research project.

There are different types of studies that discover better ways to improve people’s health and wellbeing.
  • Intervention studies look for better treatments for the root cause of a disease as well as finding better ways to treat the condition. The studies discover new treatments or ways to provide care.
  • Prevention studies test ways of preventing people from getting a certain disease or condition.
  • Diagnostic and screening studies look for better and more efficient ways to diagnose diseases.
  • Behavioral research tries to figure out how behaviors are related to a many different diseases or conditions, and how these behaviors can be changed.
  • Quality of life studies try to find better ways to improve the quality of life for people who have a disease or condition.
  • Observational studies follow individuals over time (weeks, months or years) to see how their health changes.

Research Careers and Vacancies

Senior Clinical Research Associate

Date posted: Nov 2017

About the business and the role

Pharmaceutical Solutions is an independent CRO focused on quality management of clinical trials in Australia and New Zealand. We've been around for 17 years and have a strong company culture. 

Pharmaceutical Solutions is actively recruiting for a Senior Clinical Research Associate to join our company in Australia - Permanent - home based opportunity. Melbourne or Sydney based preferred but would consider other locations.

Become part of our expert team of specialists who have enjoyed being part of many successful and interesting projects.

Job tasks and responsibilities

Position Description:

SCRA position available at PSL – Start date Jan 2018

Advantage if you have experience in Phase 1 studies and/or oncology experience

Responsibilities Of The Clinical Research Associate

  • Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
  • Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
  • Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms,  guidelines and checklists
  • Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
  • Perform pre-study initiation, monitoring and close out visits as required
  • Carry out drug formulation administration procedures and documentation records
  • Ensure adequacy of drug shipment and drug accountability
  • Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
  • Organise / attend investigator meetings as required
  • Provide support to the Project Manager with ad-hoc tasks as required
Skills and experience

Essential Criteria

  • Bachelor's degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline
  • Clear understanding of the drug development process
  • Significant experience in performing a Clinical Research Associate role 3-4 years of experience
  • Work experience within either a Contract Research Organisation or Pharmaceutical company
  • Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials
  • Ability to independently perform pre-study initiation,  monitoring and close out visits as required
  • Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines
  • Fluency in English (both written and spoken)
  • Willingness and ability to travel
  • Willingness and ability to be home based in Sydney or Melbourne, Australia
  • Citizen or Permanent Resident of Australia


Please send your CV to our Director Clinical Operations - Petro@pharmasols.com

Participate in a study

https://clinicaltrials.gov/

http://www.anzctr.org.au/