PPD Experienced Clinical Research Associate (CRA) - Midwest / Central US region- HOME BASED - TX, OK, KS, NE, SD, ND, MN, IA, MO, IL, IN, WI, MI in Austin, Texas
PPD is a leading global contract research organization providing comprehensive, integrated drug development , laboratory and lifecycle management services. Our clients and partners include pharmaceutical , biotechnology , medical device , academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
PPD offers CRAs. . . .
A clinical team approach to supporting sites, resulting in PPD CRAs being responsible for less administrative and site management tasks.
Benefits that take into consideration the needs of a CRA, a membership in an airline comfort club, a travel reward program that rewards CRAs with additional days of PTO or cash etc.
20 - 22 days of PTO Annually, 9 paid company holidays and a floating holiday
8-10 days a month on site not including travel across one to three protocols
Continued career advancement as a CRA and career advancement to home-based management opportunities.
The Clinical Research Associate (CRA) 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.
Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits. Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites. Required to travel 60-80% on average.
This position can be home-based in: California, Nevada, Utah, Arizona, Colorado, New Mexico, Washington, Idaho, Montana, Wyoming, or Oregon.
Education and Experience:
Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution
1 years experience as a field clinical research monitor (CRA) that provides the knowledge, skills, and abilities to perform the job (or completion of PPD Drug Development Fellowship).
Valid Driver's License where applicable
In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered
Knowledge, Skills and Abilities:
Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Good organizational and time management skills
Effective interpersonal skills
Attention to detail
Proven flexibility and adaptability
Ability to work in a team or independently as required
Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
Frequently drives to site locations. Frequently travels (60-80% of time) domestically with extended overnight stays.
Exposure to biological fluids with potential exposure to infectious organisms.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, with frequent 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 complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
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.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
*Job: Clinical Management
*Organization: Clin Dev-United States (CLDUS)
*Title: Experienced Clinical Research Associate (CRA) - Midwest / Central US region- HOME BASED - TX, OK, KS, NE, SD, ND, MN, IA, MO, IL, IN, WI, MI
*Location: Texas-Austin - Home Based
*Requisition ID: 141015