Clinical Research Associate (CRA) – CEMAI

Position:
Clinical Research Associate (CRA) – CEMAI
Job Type:
Permanent/Full Time
Qualification:
B.Sc, RN or equivalent degree in a biomedical discipline. Preferably previous official CRA training (participation in a CRA training course). Desired: Medical background
Skills:
Microsoft Office
Experience:
Preferably 1-2 years CRA experience in either the pharmaceutical industry or a CRO Experience in monitoring Clinical Trials in the assigned therapeutic area is desirable
Salary Range:
Negotiable (PKR)
Location:
Karachi

Purpose
• The Clinical Research Associate has a pivotal role in site management activities related to start up activities, regulatory compliance, patient enrolment, protocol adherence, CRF compliance and data quality for clinical programs so that they meet specified scientific, medical, regulatory needs as well as developing and maintaining investigator relationships

The Clinical Research Associate (CRA)


• Is a local role
• Works in close collaboration with the Clinical Trial Manager and/or Medical Director to ensure preparation, conduct and closedown of clinical programs according to ICH GCP, Company policies and procedures, international ethical and scientific standards and local regulations

• For global trials additionally works in close collaboration with Study Management Team according to communication plan per project

Responsible for:


• Working according to ICH GCP, Company policies and procedures, international ethical and scientific standards and local regulations and keep updated training file
• Performing on & off – site monitoring activities during study conduct to ensure adherence to Protocol, ICH-GCP guidelines, local regulatory requirements and SOPs
• Proper handling of safety information (SAE/AE reporting, SUSARs, SSR, ASR and IB submission) and IMP management

• Proper collection and archiving of essential study documentation
• Timely and accurately execution of Monitoring Plan and other reporting, (eg. Monitoring visits, AIMS/CTMS, Safety reporting, Data collection)
Key Activities
Depending of the type of clinical program (interventional trials or non-interventional studies) the scope of activities will differ

Principle accountabilities:
• Preparing, conducting and follow-up of pre-study site-management activities, site initiation visits, monitoring visits and close-out visits according to specific SOPs
• Overseeing and facilitating Study start-up activities, as required
• Participation in project preparation (i.e. protocol and CRF review, ICF translation, planning and tracking documents, etc)
• Participation in site feasibility, as appropriate
• Assist with preparation of required regulatory submissions
• Assist clinical sites with IRB/IEC submissions and ensure collection of required essential documents for study start-up and throughout conduct of study.
• Prepare all practical arrangements for approval by CTM or MD, as applicable
• Ensure all personnel at study sites are appropriately informed and trained, before study starts and regularly updated (as required). This will include information and training on:
– Protocol and CRF
– patient information sheets and informed consent
– SAE/AE reporting
– ICH GCP & study specific requirements – Source data verification
– HA requirements
– IEC/IRBs requirements
– IMP and other supplies management (distribution, storage and accountability)
– biological sample preparation, storage and transportation, if any
• Participate to development of any necessary aids to allow studies to proceed expeditiously (e.g. newsletter, investigator flow charts)
• Make regular contact with investigators and site staff, to ensure compliance with protocols and time schedules, and that data is accurately and timely recorded, submitted and resolved (if needed)
• Proactive identification of any quality issue and implementation of action plan (if require) or escalation
• Work with the Local Safety Responsible (LSR) to properly report and follow up SAE/AE in the timely manner
• Ensure that data are collected in CRF in a timely manner and provided to the Data Manager, as agreed
• Undertake other project related tasks as appropriate e.g. planning of investigator meetings, etc. and non project related tasks (if required)
• Track study progress using study tracking tools, ensuring timely and quality updates to the system used
• Maintain effective communication with Study Management Team members
• Prepare and participate to regular study meetings/teleconferences
Knowledge
• Knowledge of ICH GCP and GMP guidelines, regulatory requirements, medical terminology and clinical development
• Relevant knowledge on use of Clinical Trial tools (eg. Clinical Trials Management System, IVRS, etc.)

• Fluent in written and spoken English

Competencies

• Strong organizational and planning skills with attention to details
• Communication skills
• Negotiation skills
• Computer skills, ability to develop and maintain excel spreadsheets
• Ability to function independently
• Ability to travel

Regards


Adeel Akhtar
Email: adeel@hasnain.biz
Websites: www.hasnain.biz; www.getfreejob.com