PPD Experienced Clinical Research Associate (CRA) - *Client dedicated* - Central (IL, TX, KS, MO) or New England region (CT, MA) in Dallas, Texas
Title: Experienced Clinical Research Associate (CRA) - Client dedicated - Central (IL, TX, KS, MO) or New England region (CT, MA) Location: Texas-Dallas - Home Based
PPD has an exciting opportunity for an Experienced Clinical Research Associate (CRA) to join our team working exclusively for one of our large strategic pharmaceutical partners. This position can be home-based or office-based. Locations preferred for candidate to live are: Chicago, IL; Dallas, TX; Kansas City, KS; St. Louis, Missouri or New England area (CT/MA). Travel will be primarily regional-based (estimated to be 50% travel however may vary based on business needs). As part of the PPD services to this partner, this CRA will be dedicated to client-specific projects and sites, collaborating with the client’s teams under some of their systems and processes.
This is an opportunity for a clinical professional with experience supporting multiple clients/studies to enjoy working for a CRO but dedicated to one client. Ideal for experienced Clinical Research Associates or other experienced clinical professionals with relative experience working within the life science sector for pharmaceutical, biotech companies or CRO’s.
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.
Tasks performed may include but are not limited to the following:
Oversight of all sites for a study/ies they are responsible for at a country level
May have some / all of these activities of a CRA:
performing study feasibility, development and preparation of the local informed consent form, management of regulatory and / or IEC questions, management of budget and financial aspects of the study, manage the delivery of study supplies to all sites at a country level and ensure timely and correct updating of clinical systems for clinical trials. *LI-LA1 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 Clinical research monitoring experience (minimum 2 years) that provides the required knowledge, skills and abilities and experience mentoring or training others 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:
Effective clinical monitoring skills Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices and applicable Standard Operating Procedures Ability to mentor and train other monitors in a positive and effective manner Ability to evaluate medical research data and proficient knowledge of medical terminology Effective oral and written communication skills, with the ability to communicate effectively with medical personnel Strong customer focus Excellent interpersonal skills Strong attention to detail Effective organizational and time management skills Proven flexibility and adaptability Excellent team player with team building skills Ability to work independently as required Ability to utilize problem-solving techniques applicable to constantly changing environment Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software Good English language and grammar skills Effective presentation skills Working Conditions:
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. Physical Requirements:
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.