Research Tm Coord

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 Coordinator, you will be responsible for the successful conduction of multiple ongoing clinical trials involving patients or healthy volunteers/subjects .

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 general supervision of the Research Team Leader, the Research Team Coordinator (RTC) is responsible for the successful conduction of multiple ongoing clinical trials involving patients or healthy volunteers/subjects. Completes of all paperwork required to accurately capture all data specified by a study protocol, and for assuring subject safety, understanding, and cooperation during the study process.

Essential Functions: Accountable for understanding and accomplishing the overall plan for study conduct for multiple assigned studies in order to assure successful study completion with clean and accurate data for submittal to sponsor. Reviews assigned study protocols, case report forms and investigator's brochure and interfacing with the Team Leader and Project Manager to clarify any study questions prior to study start. Prepares accurate data collection sheets, dosing regimens, specimen harvest logs (e.g. blood, urine, fecal, and other specimens), and any other study documentation needed. Works with the Team Leader to ensure study flow chart and technician requirements accurately reflect the study design and to assure staffing and equipment needs for the study are met. Communicates and works with the Pharmacy, Food Service, Materials Management, Training Team and Laboratory staff to assure proper support from these areas. Keeps Team Leader and Project Manager apprised of study progress, status, and of any issues that require their attention. Monitors the day-to-day safety and wellbeing of all study participants through direct and indirect interaction with subjects. Performs accurate clinical assessments of subjects, monitors laboratory safety reports, communicates information regarding serious or potentially serious adverse events to the Project Manager and/or physician in charge. Monitors and continuous evaluation of the overall research experience for each study participant, while ensuring participants are properly consented and informed at all times . Submits authorization for payment of stipend to subjects. Complies with FDA and company guidelines (i.e., ICH-GCP, PPD SOPs, personnel policies and procedures, WPDs, PPD exposure control plan, OSHA regulations, and clinical laboratory requirements for submitting samples) in order to assure proper study conduction and employee and subject safety 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 Coordinator, you will be responsible for the successful conduction of multiple ongoing clinical trials involving patients or healthy volunteers/subjects .

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 general supervision of the Research Team Leader, the Research Team Coordinator (RTC) is responsible for the successful conduction of multiple ongoing clinical trials involving patients or healthy volunteers/subjects. Completes of all paperwork required to accurately capture all data specified by a study protocol, and for assuring subject safety, understanding, and cooperation during the study process.

Essential Functions: Accountable for understanding and accomplishing the overall plan for study conduct for multiple assigned studies in order to assure successful study completion with clean and accurate data for submittal to sponsor. Reviews assigned study protocols, case report forms and investigator's brochure and interfacing with the Team Leader and Project Manager to clarify any study questions prior to study start. Prepares accurate data collection sheets, dosing regimens, specimen harvest logs (e.g. blood, urine, fecal, and other specimens), and any other study documentation needed. Works with the Team Leader to ensure study flow chart and technician requirements accurately reflect the study design and to assure staffing and equipment needs for the study are met. Communicates and works with the Pharmacy, Food Service, Materials Management, Training Team and Laboratory staff to assure proper support from these areas. Keeps Team Leader and Project Manager apprised of study progress, status, and of any issues that require their attention. Monitors the day-to-day safety and wellbeing of all study participants through direct and indirect interaction with subjects. Performs accurate clinical assessments of subjects, monitors laboratory safety reports, communicates information regarding serious or potentially serious adverse events to the Project Manager and/or physician in charge. Monitors and continuous evaluation of the overall research experience for each study participant, while ensuring participants are properly consented and informed at all times . Submits authorization for payment of stipend to subjects. Complies with FDA and company guidelines (i.e., ICH-GCP, PPD SOPs, personnel policies and procedures, WPDs, PPD exposure control plan, OSHA regulations, and clinical laboratory requirements for submitting samples) in order to assure proper study conduction and employee and subject safety

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. Bachelors Degree preferred.

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 General computer skills including working knowledge of Microsoft Office and the ability to learn new software, systems, databases Effective problem-solving skills. Good mediation skills. Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings Ability to exercise good judgment and to maintain confidentiality Effective time-management skills Attention to detail. Strong planning and organizational capabilities to manage multiple tasks and multiple study groups at one time Ability and willingness to learn to administer investigational drugs or test investigational devices. This may include dosing orally, intravenously, topically, or other approved methods of dosing Ability to work well in a team environment and follow all internal departmental procedures

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. Bachelors Degree preferred.

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 General computer skills including working knowledge of Microsoft Office and the ability to learn new software, systems, databases Effective problem-solving skills. Good mediation skills. Ability to function with multiple types of individuals in potentially difficult or uncomfortable settings Ability to exercise good judgment and to maintain confidentiality Effective time-management skills Attention to detail. Strong planning and organizational capabilities to manage multiple tasks and multiple study groups at one time Ability and willingness to learn to administer investigational drugs or test investigational devices. This may include dosing orally, intravenously, topically, or other approved methods of dosing Ability to work well in a team environment and follow all internal departmental procedures

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