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Job #02807

About our client Our client is a rapidly growing pharmaceutical company headquartered in Massachusetts that is focused on the development and commercialization of various pains therapeutics. 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. Position Location Clinical Research Associate Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Handle the operational activities involved in the planning, conduct and completion of clinical trials, including CRF development, ordering clinical supplies, collection, review and filing of clinical trial and regulatory documents 2) Prepare monitoring guidelines and correspondence with investigative sites on routine matters concerning ongoing clinical trials 3) Assist with identification of potential investigators and clinical sites 4) Conduct study visits (pre-study through closeout) 5) Mentor less experienced CRAs (as needed) 6) Review on-site files and records, Case Report Forms and 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) Assist with the preparation of IND serial submissions 14) Develop and maintain effective working relationships with Clinical Study Team members 15) Participate in data-review process 16) Maintain in-house clinical study files 17) Participate in Clinical Study Team meetings 18) Ensure that all clinical aspects of studies are being carried out in accordance with GCP and ICH guidelines 19) Perform other activities as assigned Requirements 1) Bachelor’s degree (Biology or Life Sciences preferred) 2) Minimum 3 years CRA monitoring experience at 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 written and verbal communication skills 8) Ability to travel (as needed) – up to 25%