8 Site Initiation Jobs

Oversee construction site operations and ensure safety compliance Manage project schedules and resources Coordinate with contractors, vendors, and stakeholders Conduct quality inspections and ensure work meets specifications Required Candidate profile Bachelor’s degree in Civil Engineering or related field 3+ years of experience in site engineering or construction management Strong knowledge of construction safety standards, and project management.

Role & responsibilities Identifying/selecting an investigator who will be Responsible for The conduct of The trial at The trial site. Liaise with doctors/consultants or investigators on conducting the trial. Setting up The trial sites, which includes ensuring each centre has The trial materials, including The trial drug often known as The investigational medicinal product. Training The study staff in standard operating procedure for The clinical trials as per applicable regulatory requirements. Verify that investigator and investigators team are adequately trained and comply with The protocol. Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. Monitoring The trial throughout specified duration involving Monitoring visit to The trial sites. Source data verification Informed consent form review, case report form review, investigational drug accountability, and adverse event review. Ensuring all unused trial supplies are accounted for. Writing visit reports, filing and collecting trial documentation and reports. Preferred candidate profile Pre-requisites for - Sr. Project Executive / CRA / Sr. CRA: B. Pharm/ BSc / Biotech + Clinical Research Degree / Diploma / Masters Candidate must possess excellent communication skills and ability to build excellent relationships with the trial staff and colleagues. ICH-GCP knowledge is a must. Ready to travel within and out of Mumbai at various trial sites. Willing to travel 50-60%. Attention to detail Good organisational and administrative skills (knowledge of word and Excel) Perks and benefits Salient Features of this job Chance to work in a supportive and flexible environment. Directly interact with customers from the USA and Europe. Vedic Lifesciences has been rated highly by our alumni last 22 years, as a great place to work and learn

Responsibility 1- Off-site Monitoring • To undertake off-site visits during different phases of study period, As per study plan conduct Initial Site Visit to train and guide site personnel. • To inspect pre-requisite as per protocol and ensure site is ready for the study, undertake routine monitoring visits at predetermined frequency as per study guideline. 2-Communication & Documentation • To communicate for Feasibility Assessment Questionnaire and fetch necessary detail for review from potential sites. • To take follow-up on routine basis with off-site nodal/in-charge, prepare visit reports (Pre-study Qualification Report, Site Initiation Visit report, Site Monitoring Visit Report, Site Closeout Visit Report) as per frequency with update of study trials and submit for review. • To procure pre-requisite documents (like calibration reports, agreements, etc) fromsites and vendor at the time of study start up and during the study. •To provide various data formats (Logs and form, Source data temples, recruitment trackers, Feasibility questionnaire etc.) to off-site team and ensure capturing/recording of data as per same. 3-Audits & Compliance • To review study related documents generated during the study in accordance with various SoPs/Protocol/Regulatory requirements. • To train/guide/mentor off-site team on study protocol/Regulatory aspects (GCP, Root Cause Analysis, updated regulatory requirements etc.) periodically. • To respond/comply to queries raised by internal (QA/QC) and external (Sponsor/Regulatory) auditors. • Any other task assigned by reporting authority.

TroubleshootingSalient Features of this job * Chance to work in a supportive and flexible environment. * Directly interact with customers from the USA and Europe. * Vedic Lifesciences has been rated highly by our alumni last 22 years, as a great place to work and learn. Job Description: * Overall planning & management of Clinical trials. * Tracking trial progress, developing new study sites, project completion within agreed budget & timeline. * Identifying/selecting an Investigator & Vendor for the conduct of the trial. * Liaising with doctors/consultants or investigators on conducting the trial. * Setting up the trial sites, Training the study staff in SOP`s for CT * Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements. * Monitoring the trial throughout specified duration involving monitoring visit to the trial sites. * Source data verification * Review Investigators Brochure * Informed consent form review, case report form review, investigational drug accountability, and adverse event review. * Writing visit reports, filing and collecting trial documentation and reports * Stakeholder engagement * Sponsor communication * Team handling * Trouble shooting Pre-requisites for - Clinical Operations: * Medical / Life-sciences graduate with in-depth knowledge of Clinical Research project management & fluent English (oral and written) to communicate with global sponsors. * Having 5-8 years of project management in clinical research industry. * Ability to work independently in a complex matrix environment. Good project management skills. * Understanding of Good Clinical Practice. * Presentation, negotiation and conflict resolution skills. * Strong customer-oriented mindset * Ability to resolve issues with minimal supervision. * Willingness to act accountably in project/trial management. * Presentation, negotiation and conflict resolution skills. * Team Management, Good interpersonal skills.

Job description Remote & Full-time Opportunity for professionals with direct experience of min 2 years in disclosures. Job Description Summary The Clinical Trials Disclosure Specialist II position is responsible for the overall coordination and development of multiple disclosures deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring, ensuring adherence to relevant industry guidelines and client styles and formatting in accordance with all agreed upon timelines. Job Description Essential Functions: Independently performs/coordinates all activities for registration, maintenance, and results postings, including document redaction for clinical trials across global public registries (i.e., Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable). Ensures development of high-quality registry, redaction, and plain language document deliverables that are compliant with all applicable policies, procedures, and regulations. Performs independent quality control review of registry and/or plain language document deliverables, ensuring accuracy against all relevant source documents. Works closely with internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Clients disclosure obligations. Works with internal Client team(s) to ensure the source information is provided for disclosure activities in a timely manner. Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking. Sets expectations where necessary and reports on project statuses to manager. Escalates issues to manager in a timely manner. Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time. Maintains constructive and positive interactions with colleagues. Develops strong, lasting relationships with client teams that encourage organic new business growth. Other duties as assigned. Necessary Skills and Abilities: Strong written and verbal communication skills. Self-motivated and able to work independently. Exceptional time management skills. Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries. A proven team player who can focus on and drive goal completion. Ability to understand and apply international regulations and Client guidelines and requirements related to clinical trial transparency. Thinks proactively, takes initiative, and willingly takes on new challenges. Ability to identify areas of concern or inefficiency Works independently with good time management skills and contacts management team proactively when additional support and resources are needed. Works effectively in a collaborative team environment. Demonstrates a growth mindset and positive outlook in all work activities. Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Site engineer required(LT/HT) required for gujrart kuchch location Qualification- Any electrical Exp- min 5 yrs salary- upto 40k Wtsapp me resume at 8295842337- Mr. Bansal

YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelor's or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research Job Locations: Mumbai, Pune, Chennai

YOUR TASKS AND RESPONSIBILITIES: Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts Preparation and submission of study documents for EC permission for respective study across centers Oversee & document IP dispensing, inventory management & reconciliation Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated Investigator and site personnel training on the Study protocol, procedures, and GCP principles Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL WHO YOU ARE: Minimum qualification requirement is to have a Bachelor's or Masters degree in a health[1]related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research Relevant experience of 1-5 years minimum in the field of Clinical Research Job Locations: Kolkata, Bhubaneswar, Delhi