clinical lead
Responsibility
- reviews/creates/tracks trial newsletters, memos, mass correspondence etc
- identifies site findings with the ability to re-train, place corrective action in place with the site, and follow-up as required
- co-monitor as required to provide coaching and manage performance of CRAs
Show more +8 - prepare study documents
- assists in evaluation of vendor performance during conduct of the study
- oversee the conduct of monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines, protocol, and internal SOPs/policies
- maintains clinical trial tracking information pertaining to the study
- ensure the monitors are adequately trained on the therapeutic area and study and are prepared to train the site staff during the Site Initiation Visit and at other times to trial-specific industry standards
- assists with audit/inspection responses
- develop and monitor metrics to evaluate the monitor and site performance . In the event of performance concerns, evaluate cause and mitigate risk to the study
- prepares key reports and documents on progress of study for client or internal project manager as appropriate
Requirements
- university/college degree or certification in a related field
- A minimum of 5-7 years of field monitoring experience
- A minimum of 2-3 years Lead CRA experience
Show more +7 - good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs
- good knowledge of therapeutic area assigned
- strong knowledge of FDA regulations and ICH GCP guidelines
- excellent verbal and written communication skills; excellent interpersonal and organizational skills with demonstrated attention to detail
- familiarity with video and audio tools such as ZOOM, WebEx, GoTo Meeting, Teams, etc
- ability and willingness to travel up to 30%as needed
- experience using SharePoint site as a way of managing and organizing documents and work for the role and for the CRA team
Salary in other companies in the position clinical lead
| REFUGE | 13280 £ | 5322 £ 13280 £ |
| CHASE MEDICAL | 8000 £ | 5322 £ 13280 £ |
| PROFESSIONAL OFFICE | 8000 £ | 5322 £ 13280 £ |
| PROSPECT HEALTH | 7750 £ | 5322 £ 13280 £ |
| PETS AT HOME | 6666 £ | 5322 £ 13280 £ |
| CONCEPT RESOURCING | 6420 £ | 5322 £ 13280 £ |
| CK INVESTMENT GROUP | 6000 £ | 5322 £ 13280 £ |
| RDK CONSULTING | 5833 £ | 5322 £ 13280 £ |
| POST MY JOB | 5416 £ | 5322 £ 13280 £ |
| SANDSTONE GROUP | 5322 £ | 5322 £ 13280 £ |