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Clinical Research Associate

Pharmaceutical Product Development (PPD)

AU-Melbourne-Melbourne AU Queens Road

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

As an SIA CRA, your roleinvolves a Clinical Research Associate (CRA) and Country Approval (submission) Specialist blended role.

Essential Functions:

Candidate will be expected to conduct remote or on-site Pre-Study Visits within the APAC region according to protocol requirement, regulatory compliance and manage the required documentation. This may include but not limited to:-Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.Responds to company, client and applicable regulatory requirements/audits/inspections.Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.Contributes to other project work and initiatives for process improvement, as required.

Candidate will also coordinate with internal functional departments to ensure various site start-up activities are aligned to mutually agreed upon timelines and strategies; to drive the country/site activation according to PPD and/or client’s SOPs. These activities may include:Prepares, reviews and coordinates the EC (Ethics) and RA (MOH/Country) submissions Develops country and site-specific Patient Information Sheet/Informed Consent form documents Assists with grant budgets(s) and payment schedules negotiations with sitesAchieves PPD’s target cycle times for site. Ensures the local country study files and filing processes are set up and maintained as per PPD WPDs or applicable client SOPsDevelops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrixPPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

As an SIA CRA, your roleinvolves a Clinical Research Associate (CRA) and Country Approval (submission) Specialist blended role.

Essential Functions:

Candidate will be expected to conduct remote or on-site Pre-Study Visits within the APAC region according to protocol requirement, regulatory compliance and manage the required documentation. This may include but not limited to:-Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.Responds to company, client and applicable regulatory requirements/audits/inspections.Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.Contributes to other project work and initiatives for process improvement, as required.

Candidate will also coordinate with internal functional departments to ensure various site start-up activities are aligned to mutually agreed upon timelines and strategies; to drive the country/site activation according to PPD and/or client’s SOPs. These activities may include:Prepares, reviews and coordinates the EC (Ethics) and RA (MOH/Country) submissions Develops country and site-specific Patient Information Sheet/Informed Consent form documents Assists with grant budgets(s) and payment schedules negotiations with sitesAchieves PPD’s target cycle times for site. Ensures the local country study files and filing processes are set up and maintained as per PPD WPDs or applicable client SOPsDevelops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrixJob Qualification

Education and Experience: Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years as a clinical research monitor).

Valid driver's license where applicable.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Knowledge, Skills and Abilities: Effective clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyExcellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documentsWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solvingAbility to manages Risk Based Monitoring concepts and processesEffective oral and written communication skills, with the ability to communicate effectively with medical personnelAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issuesEffective interpersonal skillsStrong attention to detailEffective organizational and time management skillsAbility to remain flexible and adaptable in a wide range of scenariosAbility to work in a team or independently as requiredGood computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate softwareGood English language and grammar skillsGood presentation skillsWorking Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group

Job Qualification

Education and Experience: Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years as a clinical research monitor).

Valid driver's license where applicable.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Knowledge, Skills and Abilities: Effective clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyExcellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documentsWell-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solvingAbility to manages Risk Based Monitoring concepts and processesEffective oral and written communication skills, with the ability to communicate effectively with medical personnelAbility to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issuesEffective interpersonal skillsStrong attention to detailEffective organizational and time management skillsAbility to remain flexible and adaptable in a wide range of scenariosAbility to work in a team or independently as requiredGood computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate softwareGood English language and grammar skillsGood presentation skillsWorking Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.Diversity StatementPPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group

Job posted: 2020-11-24

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