Administrative Asst. (Clinical)- 6 Month Temp

The basic purpose of the Project Assistant is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.Responsibilities include, but are not limited to;Reviews regulatory documents for proper contentPerforms PPD investigator file reviews and logging of outstanding issues in project related tracking toolsLiaises with monitor and investigative sites to resolve outstanding regulatory issues identified Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departmentsAssists with the identification of potential investigators and development/distribution of initial protocol packetsCreates meeting agendas and minutesCoordinates team conference calls and distribution of meeting minutesThe basic purpose of the Project Assistant is to provide technical support to the project team. Will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.Responsibilities include, but are not limited to;Reviews regulatory documents for proper contentPerforms PPD investigator file reviews and logging of outstanding issues in project related tracking toolsLiaises with monitor and investigative sites to resolve outstanding regulatory issues identified Disseminates study related information, including project tracking updates to Clients, clinical study teams and other PPD departmentsAssists with the identification of potential investigators and development/distribution of initial protocol packetsCreates meeting agendas and minutesCoordinates team conference calls and distribution of meeting minutesEducation and Experience:Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilitiesKnowledge, Skills and Abilities:Excellent communication and interpersonal skillsExcellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyAbility to effectively analyze project specific data/systems to ensure accuracy and efficiencyFlexibility to reprioritize workload to meet changing project timelinesResponsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeoutExcellent English and grammar skillsExcellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systemsAbility to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)Ability to mentor and train new Project Assistants as needed

Working Conditions

Work is performed in an office or clinical environment with exposure to electrical office equipment. Occasional drives to site locations. Potential Occasional travel required.

Physical Demands

Frequently stationary for 4-6 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.PPD is an affirmative actionemployer that values diversity as a strength and fosters an environment ofmutual respect. PPD provides equal employment opportunities withoutregard to age, race, color, pregnancy, national origin, religion, sex, gender identity,sexual orientation, disability, veteran status or other status within any otherprotected group. Education and Experience:Bachelor's Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilitiesKnowledge, Skills and Abilities:Excellent communication and interpersonal skillsExcellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyAbility to effectively analyze project specific data/systems to ensure accuracy and efficiencyFlexibility to reprioritize workload to meet changing project timelinesResponsible for adhering to FDA Good Clinical Practices, FDA regulations, PPD/Client Standard Operating Procedures and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeoutExcellent English and grammar skillsExcellent computer skills, proficient in MS Word, Excel, PowerPoint and ability to obtain knowledge and master all clinical trial database systemsAbility to successfully complete PPD clinical training program (CAFT- Clinical Administration Foundation Training)Ability to mentor and train new Project Assistants as needed

Working Conditions

Work is performed in an office or clinical environment with exposure to electrical office equipment. Occasional drives to site locations. Potential Occasional travel required.

Physical Demands

Frequently stationary for 4-6 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional mobility required. Occasional crouching, stooping, bending and twisting of upper body and neck. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration. Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.PPD is an affirmative actionemployer that values diversity as a strength and fosters an environment ofmutual respect. PPD provides equal employment opportunities withoutregard to age, race, color, pregnancy, national origin, religion, sex, gender identity,sexual orientation, disability, veteran status or other status within any otherprotected group.