The Clinical Research Associate (CRA) is a key member of the ClinicalProject Team and is responsible for managing investigator sites forselected studies. Incumbents monitor specified sites to ensure dataintegrity and compliance with Chiltern International or Client’s SOPs,ICH GCP and or ISO 14155, regulatory requirements and the projectprotocol. Incumbents are responsible for ensuring that projects arecompleted on time and within budget.
Clinical Research Associate - 1(Entry)
1. Prepare and conduct site visits including (but not limited to):qualification visits, initiation visits, monitoring visits, motivationalvisits, audit support visits, and close-out visits according to relevantSOPs, local requirements, the protocol and project plans as well asproviding timely and comprehensive visit and status (i.e. patientrecruitment) reports under supervision.
2. Communicate effectively with Chiltern Project Team members (i.e.Clinical Team Leader, Project Managers, Safety and Data Management) toensure study completion per company and client requirements andtimelines.
3. Proactively communicate with study sites and follow-up on all openissues in order to meet the project timelines under guidance of theproject team. Ensure that all study-related documentation is tracked,printed, and filed as required by Chiltern SOPs, regulatoryrequirements, and other protocols.
4. To ensure that investigator site files are assembled appropriatelyand that all required documentation is in place, tracked and reconciledon a regular basis against the TMF files.
5. Perform other duties as required by the Department or Project Team.
Clinical Research Associate - 2 (Experienced)
1. Prepare and conduct site visits including (but not limited to):qualification visits, initiation visits, monitoring visits, motivationalvisits, audit support visits, and close-out visits according to relevantSOPs, local requirements, the protocol and project plans as well asproviding timely and comprehensive visit and status (i.e. patientrecruitment) reports.
2. Communicate effectively with Chiltern Project Team members (i.e.Clinical Team Leader, Project Managers, Safety and Data Management) toensure study completion per company and client requirements andtimelines.
3. Proactively communicate with study sites and follow-up on all openissues in order to meet the project timelines. Ensure that allstudy-related documentation is tracked, printed, and filed as requiredby Chiltern SOPs, regulatory requirements, and other protocols.
4. To ensure that investigator site files are assembled appropriatelyand that all required documentation is in place, tracked and reconciledon a regular basis against the TMF files.
5. May support in mentoring less experienced CRAs on project ordepartment tasks and requirements.
6. Perform other duties as required by the Department or Project Team.
Clinical Research Associate – 3 (Senior)
1. Prepare and conduct site visits including (but not limited to):qualification visits, initiation visits, monitoring visits, motivationalvisits, audit support visits, and close-out visits according to relevantSOPs, local requirements, the protocol and project plans as well asproviding timely and comprehensive visit and status (i.e. patientrecruitment) reports.
2. Communicate effectively with Chiltern Project Team members (i.e.Clinical Team Leader, Project Managers, Safety and Data Management) toensure study completion per company and client requirements andtimelines. Being a pro-active member in team calls and act as a rolemodel. May support in the creation of CRA working tools based on theexperience on the project.
3. Proactively communicate with study sites and follow-up on all openissues in order to meet the project timelines. Ensure that allstudy-related documentation is tracked, printed, and filed as requiredby Chiltern SOPs, regulatory requirements, and other protocols.
4. To ensure that investigator site files are assembled appropriatelyand that all required documentation is in place, tracked and reconciledon a regular basis against the TMF files.
5. May support in mentoring less experienced CRAs on project ordepartment tasks and requirements.
6. May support in conducting quality control accompanied visits withCRAs level 1 or 2.
7. Perform other duties as required by the Department or Project Team.
