Clinical Research Associate - OSG FSP – Contract/Temporary Opportunity
PPDFull time Full day
Clinical Research Associate - PPD Outsourcing Solutions Group
- Home-Based/Remote Based Contract/Temp Opportunity
- Full Time (FTE 1.0)
- 6 month duration
The PPD flexible staffing program, with our internal PPD Outsourcing Solutions Group (OSG) offers flexible work options where you can be a part of the PPD culture as a contract, temporary worker, consultant worker or freelancer.
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The Clinical Research Associate (Contract/Temp Opportunity) will perform and coordinate 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.
Conduct site visits to assess protocol and regulatory compliance and manages required documentation. Responsible for ensuring that data will pass international quality assurance audits. Develops collaborative relationships with investigation sites. Required to travel 60-80% on average.
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
- Minimal clinical monitoring experience that provides the required knowledge, skills, and abilities. In some cases previous experience (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care OR experience in a health sciences field with formal training in medical terminology and anatomy may be considered
- 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:
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- 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
- Customer focus
- Good interpersonal skills
- Good organizational and time management skills
- Attention to detail
- 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
- 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.