Clinical Research Assosiate

Mene Research A. Ş.

For our expanding global operations we are looking for CRAs / Sr. CRAs to be a part of MENE RESEARCH team:
The successful candidate should demonstrate:

CRAs:
Min. 1 year CRA experience (active monitoring) preferably in international phase I-III clinical trials .
- Bachelors degree in lifesciences, pharm. or engineering
- Advanced English (both written and oral)
- No limitation for travel

Sr. CRAs:
- Min. 3-4 years active monitoring experience (conducted site selection visits, site initiation visits and site close out visits) in international phase I-III clinical trials combined with excellent intra and interpersonal leading skills.
- Previous international audit experience is strongly preferred
- Have adequate mindset and knowledge to identify, select, initiate, monitor, close the study centers
- Understand the fundementals of GCP, acknowledge  the local regulation and guidelines
- Familiar to work in accordance with the sponsor and company SOPs
- Ability to manage the time, prioritization, follow up processes adequately
- Excellent problem solving skills with demonstrated examples
- Ability to mentor and direct and motivate CRAs and CTAs.

Please apply with your most current CV and positive previous reference is highly requested.

İŞ TANIMI

• Manages day-to-day operational aspects of a project.
• Reviews deliverables prepared by team before passing to client.
• Ensures project documents are complete, current, and stored appropriately.
  Perform co-monitoring visits with less experienced CRAs or at problem sites as required.
• To be familiar with the investigational product, the study protocol and other study related materials.
• Review clinical data to ensure its accuracy, completeness and integrity, verifying case report forms against source data.
• Maintain an exceptional working knowledge of, and ensure compliance with the ICH and FDA Good Clinical Practices, applicable regulatory and legal requirements, and MENE (or sponsor) Standard Operating Procedures.
• Co-ordinate timely shipment of clinical supplies and study drugs to each investigational site as required.
• Assure the supply and account for the disposition of clinical materials.
• Collaborate with other departments for reporting and disseminating safety information in a timely manner as defined by client contracts and applicable regulatory requirements.
• Complete routine site visits and reports as required by client contract deadlines.
• Qualify potential investigators which include obtaining patient accrual information, previous training and experience of investigator work and ensure capabilities of other study staff to carry out the clinical trial.
• Interact with investigators and CRAs/CRAssts. To obtain necessary documentation and information before, during and after the study.
• Initiate investigational sites including a comprehensive visit to ensure the clinical sites understand their obligation as required by applicable regulations to carry out a clinical trial.
• Ensure that  CRF pages or data queries are dealt with and obtain corrections to the CRF as appropriate, according to SOPs and as specified by the client.
• Track flow of clinical data at investigational sites; maintain records of status at sites and of patients.
• Ensure central files are well maintained, complete and up-to-date.
• Co-ordinate the organization, administration and presentations at investigator meetings as required.
• Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required.
• Raise any concerns and propose actions regarding the quality of the data or compliance with GCP at an investigational site, or any other project related concerns, with the Primary CRA, Project Manager or Line Manager, as appropriate.

Please kindly provide information on which position you are applying for (CRA or sCRA).