Regional Sr. CRA
Job Code: CSA1115C
Nationwide – 3+ years monitoring experience ng experience
Performs and coordinates all aspects of the clinical monitoring process
in accordance with GCPs and global SOPs to assess the safety and efficacy of
investigational products and/or medical devices. Conducts site visits to
determine protocol and regulatory compliance, and prepares required
documentation. Represents company in the global medical research community
and develops collaborative relationships with investigative sites and client
company personnel. Performs the function of mentor for junior clinical team
members. May assist the Project Manager, Senior Project Manager or CTM with
certain project management functions.
Required to travel 60-70% on average.
Education and Experience
- Bachelor’s Degree in life sciences or related field or certification
in a related allied health profession from an appropriately accredited
institution (i.e.: RN, MT, PA, RPh, RT)
- Minimum two years as a clinical monitor.
- In some cases, a combination of education and prior directly related
experience may be considered as equivalent to the above requirements
provided that the individual possesses the following knowledge, skills,
and abilities to perform the job requirements satisfactorily.
Knowledge, Skills and Abilities
- Previous successful completion of or ability to successfully
complete company training program.
- Excellent clinical trials monitoring skills to include conduction of
qualification, initiation, monitoring and close out visits.
- Demonstrated ability to mentor and train other monitors in a
positive and effective manner.
- Excellent understanding of FDA guidelines and GCPs and ability to
attain and maintain a working knowledge of applicable SOPs.
- Basic computer skills and ability to learn and become proficient
with appropriate software
- Demonstrated ability to evaluate medical research data and
proficient knowledge of medical terminology.
- Effective organizational skills and strong attention to detail.
- Effective oral and written communication skills with ability to
communicate effectively with medical personnel
- Excellent team player with team building skills.
- Strong customer focus and excellent interpersonal skills
- Ability to utilize problem-solving techniques applicable to
constantly changing environment
- Valid Driver’s License and ability to qualify for and maintain a
corporate credit card with sufficient credit line to allow for extensive
business travel
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