Fortis CRO-Openings -k

Clinical Study Coordination

Apply here

Role : Assists the clinical investigator in efficiently executing the logistics of all clinical studies at the CRO Responsibilities : Primary : To assist in preparation of protocol and its appendices To interact with the caterer to ensure timely provision of meals as per approved meal plans To ensure sufficient numbers of ICFs are available in the required languages to obtain the informed consent before start of the study To make logistical provisions required by the protocol: path lab, clinical supplies, water, meals, etc. To check vital signs sheet and adverse events monitoring sheets of subjects along with all raw data form To monitor safety parameters during clinical studies To write and revise SOPs and ensure compliance with all current policies and procedures To assist in compilation of raw data related to safety of subjects Secondary : To be available at centre during in house part of study to handle medical emergencies To check vital signs sheet and adverse events monitoring sheets of subjects To review medical screening records and ascertain suitability of subjects Volunteer selection, informed consent procedure as per defined procedure To conduct clinical examination of all subjects participating during all clinical studies Preparation of clinical report and study update

Quality Control (Bioanalytical Section)

Apply here

Role : Assist Head- Bioanalytical in ensuring GLP and applicable regulatory compliance to achieve and maintain desired quality standards Responsibilities : Ensuring strict compliance with GLP norms in the bioanalytical section Monitoring compliance with Standard Operating Procedures Checking documentation for every procedure carried out from Analysis to reporting of results Preparation of Standard Operation Procedures for various activities To coordinate monthly training sessions for the bioanalytical staff To impart training to all personnel for implementation of quality systems Preparation of the department for External Audits & Inspections Preparation of training schedule for the new employees Conduct of regular QA Audits to verify compliance to Quality Systems

Analyst

Apply here

Role : Assists the Group Leader Bioanalytical in the lab operations and execution of the study as per GLP and applicable regulatory standards Responsibilities : To participate in the day-to-day activities related to method development, method validation and study sample analysis in the lab in consultation with the group leader/ senior Analyst To procure and maintain reference standards, reagents, analytical columns etc To initiate, check and supervise the calibration/maintenance of equipment (HPLC, LC-MS/MS etc. To assist the senior scientist for checking/review of all SOPs including method SOPs, method validation reports and bioanalytical reports of the projects To anticipate and plan project related purchase activities To monitor the receipt of study samples from clinical unit Collection of literature for the projects on method development and validation Study related documentation

Instrumentation Engineer

Apply here

Role : Assists the Head - Clinical / Bioanalytical operations to provide GLP support on maintenance, calibration and validation of instruments Responsibilities : Ensure smooth functioning of the instruments by coordinate with supplier and vendors Maintenance of Instruments/equipments spare parts & inventory Maintenance of Eurotherm temperature recording system for freezers and cold room Maintenance of centrifuges Ensure appropriate documentation in instrument/equipment logbooks Calibration of all instruments and equipments Updating SOPs for all instruments and equipments Ensuring Preventive maintenance of all instruments and maintaining the schedules Maintenance of IQ/OQ/PQ documents of all instruments

Quality Control - Clinical

Apply here

Role : Assist the Head, Clinical Operations in implementing quality control activities by verifying the trial- related activities for fulfilling ICH-GCP, GLP requirements in all clinical studies at the CRO. Responsibilities : To assess and implement quality control measures at all levels to increase efficiency and work standard. To ensure studies are more compliant with SOP, Protocol and applicable regulatory guidelines. To conduct online checks during study to increase quality and to prevent sponsor and quality assurance observations. To impart training on relative SOPs’ and quality programme. To assist Head, Clinical Operations to maintain timelines in the conduct of study procedures and training. To conduct meeting and to discuss quality assurance audit observations and prevent recurrence. To review and modify the required clinical/general SOP as need arises.

Online Application Form
* represents mandatory fields Name* E-mail Address* Post Applied for * Attach bio-data here Paste bio-data here             or Email:-hr@fortis-cro.com