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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment
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Regional Clinical Research Associate South

Location Job Id#
North Carolina, South Carolina, Florida, Georgia 02775
About our client
Our client is a rapidly growing pharmaceutical company headquartered in Irvine, California that is focused in the acquisition, development and commercialization of oncology and urology therapeutics.
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Assist in identifying and selecting trial sites
2) Conduct qualification, initiation and interim monitoring closeout visits
3) Perform drug accountability
4) Ensure timely collection of appropriate regulatory documents from study sites
5) Assist in developing materials that support the conduct of clinical studies (site reference manuals, monitoring flow sheets, CRF completion guidelines, etc.)
6) Review clinical documents for accuracy and completion (1572, consents, protocols, meeting minutes, etc.)
7) Assist in preparing investigator meetings
8) Remain current with applicable regulations concerning development and conduct of human clinical trials (CFRs, ICH)
9) Communicate to investigators the rudiments of GCP and their related responsibilities
10) Demonstrate working knowledge of relevant clinical trial SOPs
11) Ensure that assigned studies adhere to approved protocols
12) Maintain a level of accuracy that minimizes data query rate and ensures data are accurately transcribed to meet SOP and audit expectations
13) Identify and provide solutions for data trends
14) Demonstrate superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies
15) Focus on meeting established schedules and prioritize tasks to meet the schedules
Requirements
1) BA/BS
2) Minimum 1 year of experience in a clinical research environment
3) Home-based CRA experience with ready office setup
4) Experience in monitoring
5) In-depth understanding of clinical research
6) Working knowledge of relevant SOPs
7) Excellent interpersonal and communication skills to establish professional working relationships with colleagues and site personnel
8) Strong organizational, planning and follow-through skills
9) Excellent language and grammar skills with ability to write clearly and concisely
10) Ability to work with MS Word and Excel (in-depth knowledge of other presentation programs a plus)
11) Ability to work well under pressure and with tight schedules
12) Ability to plan and schedule workload as well as work effectively with others
13) Ability to exercise judgment within generally defined practices and policies for obtaining data
14) Ability to resolve problems positively and professionally
15) Attention to detail and the ability to prioritize
16) Self-directed and motivated
17) Willingness to travel up to 50%

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