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 Job #03014 Email this job to a friend
About our client
Our client is a reputed, privately held CRO that is experiencing unprecedented growth. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. This is a strong opportunity for someone that wants to put their drive and initiative to work!
Position Location
Clinical Research Associate Maryland
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee operational activities involved in planning, conducting and completing clinical trials
2) Prepare monitoring guidelines and correspondence with investigative sites on routine matters concerning ongoing clinical trials
3) Assist with identifying potential investigators and clinical sites
4) Conduct study visits (pre-study through closeout)
5) Mentor less experienced colleagues
6) Review on-site files and records, CRFs as well as source documents for completeness, accuracy, consistency and compliance
7) Identify deficiencies and discrepancies as well as provide remedial training (as required)
8) Develop and implement study-specific monitoring and reporting procedures, methods, guidelines and tools
9) Train site personnel on sponsor and regulatory requirements for study conduct
10) Oversee clinical site-study activities through database lock
11) Assist with resolving queries and complete closeout visits
12) Implement patient recruitment and retention strategies
13) Develop and maintain effective working relationships with Clinical Study Team members
14) Maintain in-house clinical study files
15) Participate in Clinical Study Team meetings
16) Ensure that all clinical aspects of studies are being carried out as per applicable guidelines
17) Assist senior CRA team to ensure launch of company's overseas (India) operations
Requirements
1) Bachelor’s degree (Biology or Life Sciences preferred)
2) Minimum 3 years CRA monitoring experience at a CRO or sponsor (or equivalent experience)
3) Knowledge of FDA regulatory requirements and good clinical practices
4) Ability and desire to work in a team-oriented environment
5) Good organizational skills
6) Proficiency in MS Word, Excel and PowerPoint
7) Excellent communication skills (written and verbal)
8) Willingness to travel internationally (up to 25%)

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