Research Team Clinical Data Associate

Company Description

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!

Role Description

As a member of PPD’s Research Teams you will be offered comprehensive training to provide day to day study support and learn about Clinical Research 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. It's not just talk - our award winning training programs speak for themselves.

Responsibilities Responsible for the successful completion and filing of case report forms and source documents for clinical research studies. Responsible for working with sponsor representatives at all meetings/visits when case report form data is reviewed. The CDA also ensures all subject data is boxed as required for study archiving.Develops filing system for each study, to ensure each subject folder will be accessible to others if necessary. Ensures each folder is eventually complete and orderly with all required forms completed and audited for accuracy. Flags any discrepancies in data to be resolved by appropriate staff. Ensures proper documentation to the study file addressing any study issues so all aspects of the study are clear even years after study is completed.Reviews protocol and case report forms (CRFs) to determine study specific information.Evaluates for gaps in information and discuss omissions with Team Leader and Project Manager to develop clear criteria for case report form completion.Ensures accurate and timely completion of study CRFs to meet sponsor requirements and deadlines. Informs Research Team Leader and Project Manager of any issues/problems, which may cause delays.Ensures principal investigator signs all CRFs and is apprised of any data issues on the study.Ensure all study participants’ paperwork is complete and adequately reflects participation in the study as per FDA requirements. Boxes completed study information in accordance with the clinical archival process.Resolves any sponsor queries after the study has been completed. Ensures all case report forms and subject folders are reviewed by QA prior to review by sponsor or signature by PI. Sets up sponsor rooms prior to sponsor

Company Description

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!

Role Description

As a member of PPD’s Research Teams you will be offered comprehensive training to provide day to day study support and learn about Clinical Research 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. It's not just talk - our award winning training programs speak for themselves.

Responsibilities Responsible for the successful completion and filing of case report forms and source documents for clinical research studies. Responsible for working with sponsor representatives at all meetings/visits when case report form data is reviewed. The CDA also ensures all subject data is boxed as required for study archiving.Develops filing system for each study, to ensure each subject folder will be accessible to others if necessary. Ensures each folder is eventually complete and orderly with all required forms completed and audited for accuracy. Flags any discrepancies in data to be resolved by appropriate staff. Ensures proper documentation to the study file addressing any study issues so all aspects of the study are clear even years after study is completed.Reviews protocol and case report forms (CRFs) to determine study specific information.Evaluates for gaps in information and discuss omissions with Team Leader and Project Manager to develop clear criteria for case report form completion.Ensures accurate and timely completion of study CRFs to meet sponsor requirements and deadlines. Informs Research Team Leader and Project Manager of any issues/problems, which may cause delays.Ensures principal investigator signs all CRFs and is apprised of any data issues on the study.Ensure all study participants’ paperwork is complete and adequately reflects participation in the study as per FDA requirements. Boxes completed study information in accordance with the clinical archival process.Resolves any sponsor queries after the study has been completed. Ensures all case report forms and subject folders are reviewed by QA prior to review by sponsor or signature by PI. Sets up sponsor rooms prior to sponsor

Requirements High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationBachelor’s Degree PreferredTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experiencePrior experience managing multiple responsibilities and completion of projects in either a work or school settingStrong communication skillsAbility to clearly explain information to a wide variety of individualsAbility to speak in front of an audienceEffective problem-solving skillsAbility to function with multiple types of individuals in potentially difficult or uncomfortable settingsAttention to detail. Strong planning and organizational capabilities to manage multiple tasks and multiple study groups at one timeEffective time management skillsAbility and willingness to learn a variety of technical skills associated with medical research (i.e. taking vital signs, performing ECGs, assisting MDs in exams, and specialized procedures as needed) 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.

Requirements High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationBachelor’s Degree PreferredTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, & experiencePrior experience managing multiple responsibilities and completion of projects in either a work or school settingStrong communication skillsAbility to clearly explain information to a wide variety of individualsAbility to speak in front of an audienceEffective problem-solving skillsAbility to function with multiple types of individuals in potentially difficult or uncomfortable settingsAttention to detail. Strong planning and organizational capabilities to manage multiple tasks and multiple study groups at one timeEffective time management skillsAbility and willingness to learn a variety of technical skills associated with medical research (i.e. taking vital signs, performing ECGs, assisting MDs in exams, and specialized procedures as needed) 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.