Deep Maurya Email & Phone Number

Ahmedabad, Gujarat, India

Responsibility to select appropriately trained and qualified individuals to select investigator and investigational site.Responsible for identification & collection of necessary documents to be forwarded to Project Manager/designee to check the feasibility of site.Set up the trial site ensuring each canter has the trial materials (current protocol, CRF, ICF, eCRF, laboratory kit if applicable investigational product) are already available at site before planned initiation date.Site initiation will be schedule after receiving approval from ethics committee and regulatory onceconfirmed.Responsible for all aspects of study site initiation visits, routine monitoring and conduct of pre-study and close-out of clinical sites.Responsible for IP accountability and availability, tracking and management of all Clinical Trial relatedsupplies shipped to the sites.Conduct of monitoring visits as per monitoring plan to check compliance with study management, protocol & other requirements at all assigned sites.The overseeing Progress of Clinical trials and ensuring that it is conducted, recoded, and reported inaccordance with protocol, SOP, ICH-GCP and applicable regulatory requirements.Responsible for identification current status of enrolment at site (Screening, randomization, withdrawals, completed subject)Source data verification along with eCRF data entry completion status.

Ahmedabad, Gujarat, India

Overall site management of clinical studies ensuring that projects are progressing according to standards Protocol, SOP, GCP and other applicable guidelines. Preparation of site visits report/monitoring report including, site qualification, site initiation, site monitoring, site closeout, etc.To perform Site Qualification Visit and to prepare report within stipulated time To assist Project Manager in developing project plan including all elements listed in the project plan template as appropriate for project.To perform site initiation, visit which includes ensuring each site has the trial materials and training of site staff to trial specific and industry standards with Project Manager and to prepare reports. To prepare the site activation checklistInterim monitoring visit trial conduct at site throughout its duration which will involve visiting the study site at predefined interval to assess that the study is being done in accordance with the protocol and monitoring plan and source data verification collecting completed CRF from sites. To coordinate with sites for resolution of Data Clarification Form(DCF)To perform site closeout to ensure that site has resolve all data queries, availability of updated site file, patient file and reconciliation of the investigational product.To circulate final study report to respective sites for EC notification & archivalEnsure communication with sites for ethics committee notification of serious adverse event, study progress, protocol deviation and safety reporting.Identify and assess the suitability of facilities to use as the clinical trial siteIdentify/select an investigator who will be responsible for conducting the trial at the trial siteLiaise with doctors, consultants or investigators on conducting the trialVerify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)

Ahmedabad, Gujarat, India

Facilitates and coordinates the daily clinical trial activities.Working closely with the PI, CRC participates in an integral way in the informed consent process by communicating clearly with potential study subjects about protocol.Coordinates approval of new study agreements and contracts.Coordinates and attends sponsor Site Selection visits routine monitoring visits and study close out visits.Responds to data clarification requests in a timely manner.Maintains subject screening logs and protocol deviation logs. Maintains excel sheet, tracking updates to database of all subjects enrolled on clinical trials.Coordinates and facilitates monitoring and auditing visits.Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.Completes documentation on each study visit that is used to track all study related activities.Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable IRB/IEC and applicable regulatory requirement.Reserving the conference room and coordinate with sponsor representative for all site visits and Investigator Meetings.Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.Assists the Principal Investigator in submission of accurate and timely closeout documents applicable IRB/IEC and applicable regulatory requirement.Review Protocol, ICD (Informed consent document), CRF (Case Report form) and associated working document related to study.Ensure that the label of dispensing container, Investigational product storage box, retention sample,Ensure that all the study personnel are been trained on the study protocol and duties are appropriately delegated, before initiation of any related activities.

Ahmedabad, Gujarat, India

Review the Protocol, Informed Consent Documents, Case Report From. associated working documents related to study.Review the Trial Master File before the commencement of study.Ensure that the labels of dispensing container, Investigational productsReview all the study related documents to ensure the completeness, correctness and compliance to the protocol and SOP.Ensure that necessary action are taken for the rectification and all the findings comments, suggestion are resolved.Review the draft and final study report and suggest necessary changes if essential.Resolved the queries, observations raised by the QAD in consultation with PM,PC, Investigators.Ensure all the study documents are available as per the TMF checklist for audit.Review the screening records of all the subject to ensure the eligibility for study participation.Verify the performance check for all the clinical emergency equipment & panic button before commencements of the clinical studies.(a) Electrocardiogram (b) Defibrillator (c) Laryngoscope (d) Oxygen cylinder (e) suction machine.Monitoring of clinical facility prior to initiation of the study.(a) Pharmacy (b) Special care room (c) Ward area (d) Phlebotomy Room (e) Clinical examination Room (f) Sample separation Room(g) Entertainment Room(h)Change Room(i) Dining Room.

Clinical data managers apply their knowledge of healthcare and database management to analyze clinical data and identify trends and report them. They design and validate clinical databases, which could include designing or testing logic checks. They process clinical data, including the receipt, entry, verification, and filing of information to generate data queries after validation checks or errors identified during data entry and resolve unidentified problems.

Ahmedabad, Gujarat, India

New Delhi India

I was work with quality assurance, medical writer, screening department as trainee.

Bachelor Of Pharmacy - B.Pharm, 2Nd

Intermediate Examination, 2Nd

High School Examination, 1St