Clinical Trial Associate

Role & responsibilities

EC Submission

• To get the documents from Central Drive, print, prepare files accordingly, and dispatch them to the respective sites prior to the Ethics Committee meeting conducted at site.

SIV (Site Initiation Visit) Kits Preparation

• To co-ordinate with CRD and prepare the SIV kits, study related material (NS Bottle, Syringe & Needle, Instrument- Digital clock, thermo hygrometer, Data logger, Infusion Pump) and dispatch to the site before the Site Initiation Visit.

Logistics Activities

• To arrange the IMP (Investigational Medicinal Product) shipments at the site, coordinate with the Pharmacist Team & logistics vendor before patients randomize the study.

• To arrange the PK sample (Blood Sample) shipment and co-ordinate with the logistic vendor and deliver it to Bio Analytical Team.

Site Payment

• To draft the site invoice according to Study based patients & send it to site.

• To follow up with Site for Signed invoice, prepare Inter Office Memo with duly signed of respective sign authority (PM, HOD, COO) and submit to finance department for payment procedure and check the accordingly Clinical Trial Agreement and send it to Site.

Phlebotomist Management

• To arrange the phlebotomist as per contact and make travel plan (Tickets, advance payment, Hotel Stay for Sample collection) & send to the site before the patients randomize.

MIS & Tracker management

• Responsible for updating MIS hrs (Project related- Start up, recruitment, close out), checking revenue reorganization data receive PM and share with the finance department.

• To maintain tracker for payment at site, Instrument & project specific.

Documents Archival

• To archive study files (Central Investigator file, Case report file, data management file) after completion of the study.

Monitor Travel expenses

• To process all site visit monitor expense (CRA), check and get signature of respective authorities and submit to finance department.

• Any other task assigned by the reporting authority