Description
Clinical Research AssociateTasks carried out by the CRA may include assisting with the following:
- Development and writing of clinical trial protocols;
- Preparation of study management documents such as the Monitoring Plan, study procedural manuals, and Laboratory Manuals
- Development of informed consent forms, patient diaries and other study related documents;
- Management of study related supplies;
- Coordination of study related meetings;
- Identification and assessment of the suitability of vendors to be used as part of study conduct;
- Oversight of performance of vendors;
- Oversight of clinical trial sites;
- QC of study related documentation;
- Review of study related data and metrics;
- Set-up and conduct of investigator meetings;
- Identification of potential investigators;
- Set-up and maintenance Trial Master File;
- Management of clinical trial materials/investigational product;
- Archiving study documentation and correspondence;
- Preparation of final clinical study reports and appendices.
Requirements:
- BS/?BA degree in a life science, RN, or related field
- Able to work effectively in a small team environment, with cross-functional team members, and external vendors
- Excellent written and verbal communication and interpersonal skills
- Able to produce accurate work to tight deadlines within a pressured environment.
- Proficiency in MS Word, Excel and Powerpoint
- 3+ ? years of relevant clinical experience in a CRO, pharmaceutical, or biotechnology company (including related nonclinical experience)
- Experience in antivirals and/or pediatrics an advantage
To find out more about Real please visit www.realstaffing.com