Clinical Trial Assistant Jobs

Position: Research And Development ApprenticeshipEligibility: LGBT Applicants Only + B.Pharm/M.Pharm (2022, 2023 or 2024 pass outs) + Bangalore City candidate***The above 3 parameters in Eligibility will be considered ONLY***Qualification: (2022, 2023 & 2024 Pass Outs) B. Pharm / M. PharmStipend: INR 25,000 per month (in hand)Duration: 12 monthsCTA: Depending on performance maybe be converted into full time resources at the end of the internship periodWork Timing, General Shift: 9AM to 5 PMLocation: Bengaluru OnlyWho Can Apply - LGBT+ (Lesbian, Gay, Bisexual, Transgender+) Pharma Job Seekers who are based in and around Bengaluru only Role Requirements-Good English language skills written and verbal particularly in scientific/medical terminologyAbility to evaluate data and draw conclusions with appropriate guidance from senior team members or managerGood attention to detailGood interpersonal, presentation and communication skillsService-oriented attitude and ability to be a team player and interact effectively with all levels of personnel in an interdisciplinary and matrix environmentComputer proficiency, IT skills, the expertise and ability to work with web-based applicationsGood level of flexibility and ability to prioritize workIf you belong from LGBT Community then please send CVs at pamela@thepridecircle.com

Position: Clinical Research CoordinatorQualification Bio Science (B.Pharm/Bio Tech etc.)Experience Above 1 Year (Clinical Research Experience must) Timing General ShiftSalary 2L 2.5L (Per annum)Location Visakhapatnam/Chennai/BangaloreLanguage Know English/Kannada/TeluguJOB Description Clinical Research Coordinator To have the good knowledge of regulations and GCP guidelines. Ability to communicate properly between the physician, patient & the site head. Assist Senior CRC in Screening including informed consent process, randomization, enrolment & follow-up (including Telephonic Follow-up) process & procedures. Maintenance of Investigator Master File as per Good documentation practices & SOP including generation of source documents. Present in Site Initiation Visit, Monitoring Visits, Site Closeout Visit. CRF, e-CRF entry, Data Query resolution. Coordinate between the local/Central laboratory and courier for the shipment. Assist the pharmacist in drug accountability and temperature maintaining logs. Assist the Sr. CRC in maintaining the accountability of study materials and in scheduling study procedures. Endow the required file notes, weekly and monthly and monthly report to the reporting authority. Tracking the status of all study activities. Report Sr.DGM daily and take advice for further action.

1) Identify new sites. PIs and conduct the detailed protocol specific feasibility.2) Preparation for site selection visit3) IRB submission & approval4) Regulatory document collection5) Set-up. maintain & timely update or Trial Master File(TMF) & relevant site binders Files6) Prepare site for Site Initiation Visit (SIV)7) Assisting Principal Investigator in administering the Informed Consent Form process8) Ensure protocol adherence and Compliance; t document protocol deviations as appropriate and communicate any impacting subject safety to !he Ethics Committee. 9) Pre-screening, screening, enrolling & recruiting subjects.10) Creating and Preparing Source Documents and their templates11) Coordinate and schedule subject's regular follow-up Visit and Procedures. preventing lost to follow-up & missed visits. Maintaining regular contact With Subject Telephonically12) Manage Clinical Trial Materials (CTM ). accountability, distribution & logistics at site13) Filling the case reports forms and Electronic case report forms and resolving all data queries within timelines.14) Reporting and coordinating all Adverse Events & Serious Adverse Events according to their timelines.15) Filling up and maintaining trial related logs like drug dispensing logs, subject logs. investigational Product t Logs, temperature logs. Etc. 16) Maintaining Calibration records of Instrument used for the trials.17) Preparing Site for monitoring & audit visits. Coordinate close out visit & archival at site.18) Communicating all protocol-related issues problems to the appropriate management staff including but not limited to questions regarding the conduct of clinical trials. Concerns regarding possible serious adverse events or subject compliance.19) Co ordinate central lab logistics & sample flow. Review lab data & communicate abnormal values to the primary care provider(if appropriate) & investigator.20) Co ordinate subject reimbursements.21) Performing all the above activities i