Clinical Research Associate

**Position : Clinical Research Associate**

(4-5 years M. Pharma or higher only; with BA/BE experience only)

Requirements to communicate effectively coordinate and plan and execute the study activities responsible for ensuring understanding of the reporting employees on the study and be accountable for all work done.

Excellent communication skills (spoken and written) in English Gujarati, Hindi and others.

Capable of handling and managing work challenges effectively and in time.

**Responsibilities**:

- Reviewing of pre-study requisites and Trial master files’ compilation and completeness (TMF) prior to project initiation.
- Reviewing request for issue of controlled document/ CRFs and general study documents from QA prior to study.
- Review of received CRFs and general study documents from QA for requested Vs issued documents.
- Review and maintain record of volunteers’ entry & exit into and out of facility during screening, check-in, ambulatories and check-out, ICF etc.
- Online monitoring of volunteers’ registration and screening process (activity) for compliance to SOP and/ or Protocol or study specific requirements and review of registration and screening documents for completeness and accuracy of data as compared to the actual activity performed on the same day of the activity.
- Review and give clearance for laboratory test requisition after checking for any study specific tests or special tests at the time of screening/ check-in.
- Review of compiled screening documents after PI evaluation but prior to volunteers’ check-in and reviewing eligibility as per protocol or study specific inclusion/ exclusion criteria.
- On check-in days, reviewing of site/ clinical facility/ cleaning records and relevant log books for preparedness and pre-check-in status as a part of preparation for the study.
- Review study plan and staff protocol training records and delegation of study specific activities. Ensure SOP training where required against activity delegated before study initiation.
- Check (for calibration, PM, completeness of log books) and give clearance for use of any and all instrumentation in the clinical department planned for use in the specific study.
- Review and ensure compilation of the printouts of communications to Hospital/ Dietician/ Ethics committee etc., regarding study dates for emergency management/ diet/ readiness prior to study initiation. Ensure timely filing of the same into the relevant sections of the TMF.
- Review and share dietician approved meal menu for the study and send communication to food caterer/ vendor along with request for meal (as per SOP) along with the study dates prior to study initiation.
- Review of meal received from vendor vs meal request as and when received and report non compliances if any to supervisor immediately on the same day.
- Online monitoring of pre-dose meal (dinner) weighing, distribution, consumption and online review of the relevant document. Ensure completeness and accuracy of documentation of the activity. To report immediately on the same day of any non-compliances.
- Online review of pre-dose activities and the relevant CRFs (vitals / cannulation records vs actual cannulation site and time/ fitness for dosing by investigator/ records of IP receipt from pharmacy/ Randomization codes vs labels vs IP containers) prior to dosing.
- Perform study drug administration during study periods. Accurately document the dosing forms and return of unused IPs with complete accountability of IPs. Ensure light/ environment conditions are met for specific products.
- Online monitoring of study activities (sample collection, vitals, meal verification, meal weighing and meal distribution, meal consumption, Vitals, review of AE documentation and concomitant medication, etc.) and CRF documentation.
- Perform online review of documentation by phlebotomists, nurses, PI, CI and any other staff involved in the study and take adequate corrective actions immediately on the same day after discussing with QA/ PI/ supervisor for adequacy of CAPA if any.
- Ensure that the phlebotomy activities are performed as per the SOP/ Protocol [ice bath, monochromatic light, bedside collection, sample volume etc., but not limited to].
- Monitor, Identify any study/ protocol/ SOP deviations during conduct [sampling, vitals, meals, separation, AE monitoring, ECG, documentation etc.], of the study/ project and ensure necessary documentation (filing deviations) on the same day of the activity/ deviation.
- Reconciliation of executed CRFs from the respective teams [Phlebotomy, Nursing, Custodian, PI/ CI etc].
- Reviewing the sample separation, storage, transfer, hemolysis, missing sample details and documentation during and again at the end of each period.
- Submitting the study documents period wise to QA for review if required by study timelines.
- Conduct a close out meeting with the staff and PI/ CI at the end of each period to discuss the deficiencies, deviations, and documentation err