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Patient Screening Associate

Pharmaceutical Product Development (PPD)

US-TX-Austin-Austin TX Metro Center Dr 2

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Phase I and IB trials represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

As a Research Team Recruiter, you will be provided comprehensive training to successfully recruit subject volunteers for multiple ongoing clinical trials involving patients or healthy volunteers/subjects while working in a hands-on team-oriented environment.

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:

Under the general direction of the Research Team Leader, the Research Team Recruiter is responsible for the successful recruitment of subject volunteers to participate in Phase I research studies. Provides the Informed Consent Session as delegated by the Principal Investigator. Prepares all required paperwork (source documents, lab requisitions, clinical labels, physical forms, etc.) required to accurately capture all data required by a study protocol in regard to subject inclusion/exclusion criteria.

Essential Functions:

Reviews protocols to determine study specific inclusion/exclusion information. Evaluates for gaps in information and discusses omissions with Team Leader and Project Manager to develop clear criteria.

Sets up screenings for participants. Sets up the number and times of screenings and physicals to meet team and staffing needs. Keeps the Senior Research Technician staff apprised of screening times to ensure adequate help with procedures. Arrives 15 minutes prior to scheduled screening with complete screening paperwork for the required number of screening participants.

Conducts the Informed Consent session by reading aloud the most recently approved version of the Informed Consent to volunteers while the volunteers follow along with their own copies.

Ensures each subject screened has been properly consented, has a signed informed consent, and all questions answered prior to any procedures being performed and continuing in the screening process.

Ensures all study participants’ paperwork is complete and adequately reflects their participation in the study screening process. Ensures all subjects’ and screening failure paperwork is kept with the study to meet FDA requirements.

Ensures physician reviews all clinical labs, ECGs and other tests as required.

Develops screening tools and source documents to ensure adherence to all inclusion/exclusion criteria. These documents include Medical History, Physical Exams, Study Dates and Information, Study Demographics, Study Admission Records, Alcohol/Tobacco Consumption, Screening Log, Sign-in Sheets, Volunteer Tracking Form and any other form required. Reviews computerized phone-screening tool for accuracy.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Phase I and IB trials represent the first practical tests of a compound’s clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover, they set the stage for subsequent studies that will ultimately determine your compound’s efficacy, safety and positive impact on patient’s lives.

As a Research Team Recruiter, you will be provided comprehensive training to successfully recruit subject volunteers for multiple ongoing clinical trials involving patients or healthy volunteers/subjects while working in a hands-on team-oriented environment.

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:

Under the general direction of the Research Team Leader, the Research Team Recruiter is responsible for the successful recruitment of subject volunteers to participate in Phase I research studies. Provides the Informed Consent Session as delegated by the Principal Investigator. Prepares all required paperwork (source documents, lab requisitions, clinical labels, physical forms, etc.) required to accurately capture all data required by a study protocol in regard to subject inclusion/exclusion criteria.

Essential Functions:

Reviews protocols to determine study specific inclusion/exclusion information. Evaluates for gaps in information and discusses omissions with Team Leader and Project Manager to develop clear criteria.

Sets up screenings for participants. Sets up the number and times of screenings and physicals to meet team and staffing needs. Keeps the Senior Research Technician staff apprised of screening times to ensure adequate help with procedures. Arrives 15 minutes prior to scheduled screening with complete screening paperwork for the required number of screening participants.

Conducts the Informed Consent session by reading aloud the most recently approved version of the Informed Consent to volunteers while the volunteers follow along with their own copies.

Ensures each subject screened has been properly consented, has a signed informed consent, and all questions answered prior to any procedures being performed and continuing in the screening process.

Ensures all study participants’ paperwork is complete and adequately reflects their participation in the study screening process. Ensures all subjects’ and screening failure paperwork is kept with the study to meet FDA requirements.

Ensures physician reviews all clinical labs, ECGs and other tests as required.

Develops screening tools and source documents to ensure adherence to all inclusion/exclusion criteria. These documents include Medical History, Physical Exams, Study Dates and Information, Study Demographics, Study Admission Records, Alcohol/Tobacco Consumption, Screening Log, Sign-in Sheets, Volunteer Tracking Form and any other form required. Reviews computerized phone-screening tool for accuracy.

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Demonstrated ability managing multiple responsibilities and completion of projects in either a work or school setting.

Strong communication skills.

Ability to clearly explain information to a wide variety of individuals.

Ability to speak in front of an audience.

Effective problem-solving skills.

Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings.

Attention to detail. Strong planning and organizational capabilities to manage multiple tasks and multiple study groups at one time.

Effective time management skills.

Ability and willingness to learn to administer investigational drugs or test investigational devices. This may include dosing orally, intravenously, topically, or other approved dosing methods.

Working 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 and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds.

Able to work in non-traditional work environments.

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

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

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

PPD’s Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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.

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Demonstrated ability managing multiple responsibilities and completion of projects in either a work or school setting.

Strong communication skills.

Ability to clearly explain information to a wide variety of individuals.

Ability to speak in front of an audience.

Effective problem-solving skills.

Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings.

Attention to detail. Strong planning and organizational capabilities to manage multiple tasks and multiple study groups at one time.

Effective time management skills.

Ability and willingness to learn to administer investigational drugs or test investigational devices. This may include dosing orally, intravenously, topically, or other approved dosing methods.

Working 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 and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds.

Able to work in non-traditional work environments.

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

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

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

PPD’s Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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.

Job posted: 2021-04-06

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