Clinical Research Associate
Дата размещения вакансии: 01.12.2022
1) Act as DRL’s direct contact with assigned sites, assess and ensure overall integrity of study
2) Implementation and adherence to study protocol at clinical investigational sites, and resolve site issues. Escalate issues that were unresolved to COL/PL.
3) Build and maintain relationships with investigators and site staff.
4) Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
5) Ensure adequate oversight to clinical trial by Investigator throughout.
6) Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation and communication.
7) Address/evaluate/resolve/escalate issues pending from the previous visit, if any.
8) Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
9) Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
10) Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents, IRB / IEC periodic updates as applicable.
11) Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
12) Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
13) Conduct remote visits/contacts as requested/needed and generate visit reports, as applicable
14) Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
15) Review & follow-up site payment status.
16) Follow-up on CRF data entry, query status, and SAEs.
17) Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
18) Review / QC of TMF (Site / country part) includes review of ISF (during on site MVs) and CIFs (in house)
- Good understanding on conduct of clinical trials, awareness about regulatory guidances for the conduct of clinical trials in India and other regularatory agencies'
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), electronic CRF (at least few platforms), RTSM or any other study related platforms / portals and MS-Office products such as Excel and Word.
- Minimum of 2 - 4 years of relevant experience; preferred with experience of handling of Global clinical trials
- Knowledge of ICH GCP, applicable local regulations;
- Proficient computer skills (MS office, Sharepoint management);
- Language skills- Bi-lingual (English and local language proficiency)
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