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| Job #02665 |
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| About our client |
| Our client is a rapidly growing biopharmaceutical
company headquartered in Long Beach that is focused on the development and
commercialization of skin healthcare therapeutics. The company has marketed
products, an experienced management team, and an empowering corporate culture
that is focused on the professional development of its employees; this is a
great opportunity for the right candidate. |
| Position |
Location |
| Senior Clinical Research Associate |
Long Beach, California |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Coordinate/execute clinical research activities
for multiple or complex single studies
2) Handle day-to-day field operations, including overseeing CROs, contract CRAs
and vendors with guidance from senior management
3) Manage assigned studies through all phases of study process, including
budgets and timelines
4) Plan, forecast and manage study logistics and develop study operation
documents and data collection forms
5) Identify, qualify, train and manage study sites, as well as conduct and
document study per protocol, GCP/ICH guidelines and SOPS
6) Ensure that data quality and study-related documents adhere to protocol,
government regulations and other relevant regulations along with GCP/ICH
guidelines
7) Identify study site issues through documented site reports and other sources
of information and bring them to the attention of the senior management
8) Evaluate and select new study investigators under the direction of the senior
management
9) Maintain Project Tracking System (updated with current study status)
10) Provide accurate progress reports on assigned studies
11) Participate in cross-functional departmental meetings and interface with
personnel directly or indirectly involved in the management of the clinical
studies |
| Requirements |
1) Bachelor's/Master’s degree in Life Sciences
2) 5 – 8 years of CRA experience in the bio-technical and/or pharmaceutical
industry
3) Experience in managing multiple projects simultaneously with aggressive
timelines
4) Experience and demonstrated ability to work at a high level of productivity
with minimum of infrastructure
5) Good understanding of statistics and protocol development for new products
6) Ability to adapt to other personalities in a respectful manner that is
conducive to goal achievement, good judgment, professionalism and independent
interfacing with CROs, study coordinators and investigators
7) Ability to organize and manage CROs, consultants and multiple KOL sites
participating in a clinical study
8) Ability to interpret and evaluate clinical data and literature
9) Ability to identify study-related, CRO- or site-related issues, determining
the causes and possible solutions to the problem
10) Detail-oriented
11) Proficiency in MSWord, Excel and PowerPoint essential
12) Excellent written and verbal skills
13) Willingness to travel – up to 50% (as needed) |

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