Careers

We are currently recruiting for following three positions:-

1) QUALITY ASSURANCE MANAGER

Responsibilities

Continued maintenance of a clinical QA System with written standard operating procedures (SOPs)
Preparation of quality assurance department with its all related SOPs
Conduct of quality reviews of protocols, CRFs and supplemental study documentation for each clinical study.
Measuring all client satisfaction through personal interview, focus group interview and questionnaire.
Quality audits of tables, data listings, and study reports for data management projects.
Conduct internal process audits and external site audits to assess compliance with SOPs, GCP and regulatory requirements
Communication with management about quality issues or problems
Will be responsible for institutionalizing standards by developing and communicating SOPs for Quality of clinical operations processes, incorporating the ICH and GCP guidelines.
Plan and carryout GCP audits, influence and ensure corrective measures, thereby ensuring the standards of adherence to GCP by the clinical study professionals are continuously enhanced.
Will be responsible for coordinating all sponsor audits, develop a plan for addressing the observations and ensure time-bound correction of the audit points.
Will audit prospective service provider from the perspective of GCP and applicable regulations and provide his considered opinion, leading to development or otherwise of a business relation with the service provider.
Advise and prepare strategic audit plans of internal audits to cover the main operation and ensure that the planned audits are conducted and reported.

Qualifications

More than 3 years experience required
Excellent English communication skills, both written and oral.
Clinical research background is a must.

2) MEDICAL WRITER

Responsibilities

Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies.
Design CRF reflecting study protocol.
Review Edit check specifications with Data Management.
Participate in the development and review Statistical Analysis Plans.
Review clinical site operational questions during conduct of the clinical trial with management and other functional area input, work with Project Management to establish and revise timelines for studies/projects.
Write the Clinical study report
Review clinical supplies package diagram and labeling.
Assist in planning Investigator Meetings.
Responsible for advisory board and regulatory agency meetings (provide the meeting report).
Assist in preparing briefing books, abstracts, manuscripts, poster presentations of clinical study findings and results.

Qualifications

2-3 experience required
Excellent English communication skills, both written and oral.
Clinical research background is a must.

3) FARSI SPEAKING Clinical Research Associate (CRA) to be based in Dubai

Responsibilities:-

Conduct on-site clinical monitoring which includes: document review, ensuring accurate data recording, verifying patient data, adherence to the protocol of a clinical trial in accordance with GCP/ICH guidelines, and Excel’s/sponsor’s SOPs.
Perform on-site visits, including site qualification, initiation, monitoring and closeout visits.
Maintain all files and documentation pertaining to studies.
Motivate investigators in order to achieve recruitment targets.
Maintaining regular contact with study sites to ensure protocol/GCP compliance.
Communicate progress of study and relevant information to Project Manager and other project team members.
Complete accurate study status reports in time.
Deal with CRF queries in a timely manner.
Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
Ensure correct archiving of files on completion of a study.

Qualifications

Medical, Pharmacy or Life Sciences degree.
MSc and PhD holders would be an added advantage.
Excellent English and Farsi communication skills, both written and oral.

Skills Required

Intermediate computer skills.
Be able to work in a team.
Should have responsible and mature attitude.
Possess interpersonal skills, effective communication skills and a positive diplomatic attitude in dealing with people.
Able to travel to Iran region .
Ability to use own initiative and pay close attention to detail.
Excellent organizational skills.
Independent, responsible, and self motivated.
International Valid driving license

Please forward your CV/resume with the position mentioned in the subject along with a cover email to us at jobs@clinart.net