Sr. Clinical Research Associate

Duties:  The Regional Senior CRA will ensure timely conduct of clinical studies according to protocols, Good Clinical Practices, SOPs, company policies and local regulations.  Serve as regional Clinical trial Lead for one or more studies; is responsible for coordination of clinical study team and management of resources.
Prior to study start, the Regional Senior CRA:
• Reviews draft study documents including protocol, CRFs and Informed Consent Forms, assists in their design/preparation and gives input to Cluster Clinical Study Coordinator
• Assists in the preparation of regulatory submission package of appropriate documents according to local regulations
• Coordinates the preparation of ethics submission package of appropriate documents according to local regulations
• Ensures all local regulatory approvals are in place for execution of the study prior to study start (in co-operation with Regulatory Affairs)
• Ensures proper local printing of the study case books, if applicable (i.e. CRF, diary cards, Informed consent forms, etc.).
• Ensures local regulatory compliance in order to have investigational medicinal product on site when requested by protocol.  Co-ordinates the delivery of clinical trial materials with cluster CSC and Global Clinical Supply
• Ensures availability on site of other clinical supplies bought locally (i.e. syringes)
• Assists in the preparation of the Investigator Financial/Third Party Service Agreement in collaboration with legal and purchase departments
• Assesses investigator’s staff and facilities (working areas, laboratory facilities, temperature controlled storage, etc.) as appropriate
• Organizes pre-study activities and conducts site initiation visits to investigators and their staff, reviews protocol and study procedures and perform relevant trainings as appropriate
• Trains Field Monitors/CRAs of CROs
• Contributes actively to conduct of investigator meetings
• Ensures proper handling of biological samples including shipping of specimens from investigational sites
• Ensures appropriate information flow with internal and external partners if applicable

During study conduct and completion the Regional Senior CRA:
• Provides necessary support to internal and external (CRO) Field Monitors/CRAs (e.g.: regular phone contact, resolution of questions)
• Provides necessary support to investigators and site staff (e.g.: regular phone contact, resolution of questions, discussion of trial issues and agreements with investigator and his/her staff) in conjunction with Medical Monitor
• Ensures appropriate action to fulfill Project management activities deadline for submission of clinical trial data to Data Management
• Ensures filing of the study related documents according to GCP-ICH
• Follows-up of SAE & International Safety Reports
• Maintains accurate and up-to-date information in CTMS
• Manages and coordinates external vendors if appropriate
• Initiates and follows-up payments to external vendors and investigators in accordance with the budget planned in adherence to Financial Agreement time points
• Reviews draft study report and gives input to cluster Clinical Study Coordinator    

Skills:  Knowledge in good clinical practice standards (e.g. ICH guidelines) and international and local regulations (e.g. FDA,EMEA)
- Excellent communication and presentation skills (both written and verbal)
- English Proficiency
- Computer literacy
- Ability to work in teams with geographical and cultural diversity
- Attention to detail, good organizational skills
- Proactive approach to problem solving
- Ability to work independently and demonstrated team-leadership skills abilities
- Ability to adapt to fast changing environment, prioritize, sound judgment and discretion
- Ability to lead and motivate others. 

At least 4 years experience as Clinical Research Associate comparable to client experience and scope, including the following:
• Monitoring activities
• Study site management
• Manage/mentor CRO personnel and other vendors
• Study coordination including submissions of documentation to ethics committees and/or regular authorities, management of investigational product
• Contribution to writing of clinical study reports    

Education:  Bachelor's Degree

BS Degree w/at least 4 years experience as Clinical Research Associate comparable to client experience and scope, including the following:  Monitoring activities, Study site management, Manage/mentor CRO personnel and other vendors, Study coordination including submissions of documentation to ethics committees and/or regular authorities, management of investigational product, Contribution to writing of clinical study reports, Not Specified