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Sr CRA (Level I)

Pharmaceutical Product Development (PPD)

TW-Taipei City-Taipei City TW XinYi Road

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD’s Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. The Sr. Clinical Research Associate (CRA) ensures the highest quality review of data and effective interaction with study sites. They conduct on-site monitoring visits throughout the study to help our client deliver life-changing therapies to patients. The Sr. CRA also performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures.

Responsibilities:

Conducts site visits to assess protocol and regulatory compliance and manages required documentationResponsible for ensuring that data will pass international quality assurance auditsRepresents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnelMay assist project manager or clinical team managers on assigned projects

Grow within the CRA career path to Sr CRA II or PCRA or develop into a line manager role. CRAs often transition to our client dedicated teams and to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

PPD’s Clinical Monitoring Team is made up of monitors with institutional knowledge, in-depth therapeutic experience, and robust operational tools to help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. The Sr. Clinical Research Associate (CRA) ensures the highest quality review of data and effective interaction with study sites. They conduct on-site monitoring visits throughout the study to help our client deliver life-changing therapies to patients. The Sr. CRA also performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures.

Responsibilities:

Conducts site visits to assess protocol and regulatory compliance and manages required documentationResponsible for ensuring that data will pass international quality assurance auditsRepresents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnelMay assist project manager or clinical team managers on assigned projects

Grow within the CRA career path to Sr CRA II or PCRA or develop into a line manager role. CRAs often transition to our client dedicated teams and to becoming CTMs working alongside our Project Management team responsible for clinical deliverables on our studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect Next

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview. Qualifications

Education and Experience:Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institutionPrevious experience as a clinical research monitor (comparable to 2 years) that provides the required knowledge, skills and abilitiesValid Driver's License where applicableIn some cases an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be consideredKnowledge, Skills and Abilities:Effective clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyExcellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating ProceduresEffective oral and written communication skills, with the ability to communicate effectively with medical personnelStrong customer focusEffective interpersonal skillsStrong attention to detailEffective organizational and time management skillsProven flexibility and adaptabilityAbility to work in a team or independently as requiredGood computer skills and knowledge of Microsoft Office with the ability to learn appropriate softwareGood English language and grammar skillsGood presentation skillsPPD 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 mannerAble to work upright and stationary for typical working hoursAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay have exposure to potentially hazardous elements typically found in healthcare or laboratory environmentsThis role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

Qualifications

Education and Experience:Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institutionPrevious experience as a clinical research monitor (comparable to 2 years) that provides the required knowledge, skills and abilitiesValid Driver's License where applicableIn some cases an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be consideredKnowledge, Skills and Abilities:Effective clinical monitoring skillsDemonstrated understanding of medical/therapeutic area knowledge and medical terminologyExcellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating ProceduresEffective oral and written communication skills, with the ability to communicate effectively with medical personnelStrong customer focusEffective interpersonal skillsStrong attention to detailEffective organizational and time management skillsProven flexibility and adaptabilityAbility to work in a team or independently as requiredGood computer skills and knowledge of Microsoft Office with the ability to learn appropriate softwareGood English language and grammar skillsGood presentation skillsPPD 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 mannerAble to work upright and stationary for typical working hoursAble to work in non-traditional work environmentsAble to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay have exposure to potentially hazardous elements typically found in healthcare or laboratory environmentsThis role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

Job posted: 2020-06-04