Clinical Research Associate

Overview:
A Clinical Research Associate (CRA) is responsible for conducting monitoring activities at a clinical site(s) for a clinical trial(s).The CRA may be responsible for multiple projects and must be able to work both independently and in a team environment.

The CRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct.

The CRA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.

The CRA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.

The CRA will have to anticipate, recognize and resolve issues in the served study sites.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation.

**Responsibilities**:

- Review and/or input to study protocol, CRF and validation tools
- Preparation and/or review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc
- Prepare the submission to the Independent Ethics Committees (central and local) and when applicable to Competent/Regulatory Authorities
- Assists in developing of Investigator and Institution contracts and budget template, negotiates budgets with sites and arranges site payments
- Participates to Investigators selection/feasibility: e.g. phone contacts, questionnaire in the appropriate country
- Conduct of site qualification visits (pre-study visits)
- Conduct of site initiation
- and site close out visits
- Conduct of regular monitoring visits
- Ensures that the site is equipped with all necessary supplies for timely reporting and that the procedures (sampling storage and shipment logistics) are appropriately adhered to
- Writes a corresponding site visit follow-up letter for the purpose of on-site quality optimization
- Distributes any documents collected during the monitoring visit to the appropriate department (data entry, assistants for archiving etc.)
- Responsible for the quality of data from his/her own sites
- Resolves questions/issues with investigator/trial staff including query verification
- Resolves and writes Data Clarification Forms, and reviews data-listings
- Manages his/her own visit schedule, appointments and the following-up of issues between visits under, along with regular communication with the sites and the clinical study team
- Maintain close contact with the investigators on-site, the centre study coordinator the pharmacist and other involved parties to be aware of any possible patient enrolments, the enrolled patients’ status, the IP stock and any further site requests or problems
- Filing and update of study documentation in the Investigator Site File and Pharmacy File (if applicable) and the TMF or Project File within the Clinical office throughout the study
- Review of Trial Master File (TMF) and ensure that all documents are in order, logical, accurate, complete, up-to-date and ready for a study audit and/or inspection
- Participates in relevant job/study related trainings
- Participates in investigators meetings and assists in the preparation of these meetings
- Performs activities in other clinical research areas according to the directive of superior
- Provide project specific training/mentoring to new team members
- Perform co-monitoring training with new CRAs

Qualifications:

- 1-3 years of monitoring experience or combination of on-site monitoring and clinical research experience or education; industry certification preferred.
- The ability to perform travel up to an average of 80%, depending on project needs
- This role may be office and/or home-based/field-based however regular infrequent visits to a Company office will also be required.

**Minimum Training Requirements**
- Applicable Standard Operating Procedures
- Good Clinical Practices (ICH Guidelines; Good Quality Practices) and local regulations
- 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidances; Computerized Systems Used In Clinical Trials)
- Good Clinical Data Management Practices
- HIPAA /GDPR, as applicable
- Drug Development and Regulatory Approval Processes (depending on applicable territory(ies)

**Language**
- You must be fluent in the language of the territory you are assigned to as well as written and oral English (any additional languages would be appreciated).

**Other Requirements**

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