Website Translational Health Science and Technology Institute
Name: Clinical Research Associate (Quality)
No. of Post: 02
Monthly Remuneration: Rs. 66,000/-
Age limit: 35 years
Qualification: Graduation degree in LifeSciences/ Pharmacy/ Public Health from a recognized university with three (3) years of post-qualification experience in clinical trial monitoring or as a clinical site coordinator.
OR
Master’s degree in Life Sciences/ pharmacy/ Public Health or other related discipline from a recognized university with atleast one (1) year of post-qualification experience in clinical trial monitoring or as a clinical site coordinator.
OR
MBBS/ BDS/ BHMS/ BAMS/ BPT with atleast one (1) year of postqualification experience in clinical trial monitoring or as a clinical site coordinator.
Skills required-
Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
Computer skills, including proficiency in Microsoft Office applications.
Strong written and verbal communication skills including good command of English required.
Excellent organizational and problem-solving skills.
Effective time management skills and ability to manage competing priorities.
Job Description:
Conduct monitoring visits for assigned trial protocols and trial sites. Overall responsibilities are to ensure that the trial is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
Performs site monitoring throughout the trial, which involves visiting the trial sites on a regular basis (from site initiation to site closeout) in accordance with the contracted scope of work.
Completes appropriate therapeutic, protocol, and clinical research training to perform job duties.
Setting up the trial sites such that each centre has the trial materials, including the trial supplies, while ensuring all trial supplies are accounted for in the study.
Administers protocol and related trial training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
May provide training and assistance to junior clinical staff.
Creates and maintains appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports and other required trial documentation.
Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment, and enrolment, CRF completion and submission, and data query generation and resolution.
Verifying that data entered into the CRFs is consistent with participant clinical notes (source data/
document verification) and clinical processes.
Writing monitoring visit reports.
Filing and collating trial documentation and reports.
Archiving trial documentation and correspondence.
Evaluate the quality and integrity of trial site practices related to the proper conduct of the protocol and
adherence to applicable regulations.
Escalates quality issues to the Quality Manager, Project Manager, and/ or senior management.
Work with the Clinical Portfolio Management department as directed and with other internal departments on their requirements as and when required.
Willingness to travel.
The selected candidates will be posted at our clinical sites situated at Puducherry and Bilaspur.
2.
Post Name: Quality Manager
No of Post: 01
Monthly Remuneration: Rs. 87,000/-
Age Limit: 45 years
Qualification:
Post-Graduation degree in Life Sciences/ Biomedical Sciences/ Pharmacy/ Public Health, from a
recognized university with four (4) years of demonstrated experience in clinical trial monitoring or clinical site management experience. The candidate must possess a valid GCP certificate.
Desirable –
Two (2) years’ of work experience in the area of Quality Control and Quality Assurance inclinical research.
Skills required-
Good understanding of needs for projects and job responsibilities.
Extensive knowledge of GCP/GLP, observational studies, and appropriate regulations and guidelines.
Ability to develop and implement clinical and laboratory monitoring plans, SOPs, database concepts, and formats.
Ability to build effective project teams, motivate others,delegate, drive, and make timely/ quality decisions.
Operational skills including focus and commitment to quality management and problem solving.
Influencing skills including negotiation and teamwork.
Effective communication skills to provide timely and accurate information to all stakeholders.
Ability to assess noncompliance situations, recognize the potential or actual broader strategic risk to
the project and escalate when needed.
Ability to identify systematic causes of complex quality problems and recommend long-term solutions.
Create a fair and ethical culture that fosters high standards of ethics.
Basic business computer skills (MS Word, Excel, e-mail).
Job Description:
Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
Performs site monitoring throughout the trial, which involves visiting the trial sites regularly (from site initiation to site closeout) per the contracted scope of work.
Actively lead or assist activities related to Internal Quality improvements and CAPA (Corrective and Preventive Actions).
Ensure that the assigned study is conducted in accordance with study protocols, GCP guidelines, and applicable regulatory requirements.
Lead or assist with identifying nonconformances with requirements, provide suitable recommendations, and facilitate ongoing quality improvements using a risk-based methodology.
Proactively identify the project risks and assist in training study staff in good clinical and documentation
practices.
Maintain GCP-compliant processes that control the quality of work at the study sites.
Complete appropriate therapeutic, protocol, and clinical research training to perform job duties.
Setting up the trial sites such that each centre has the trial materials, including the trial supplies, while
ensuring all trial supplies are accounted for in the study.
Administers protocol and related trial training to assigned sites and establishes regular lines of
communication with sites to manage ongoing project expectations and issues.
Conduct source document verification and case record forms for assessing the study trends.
Management of essential documents for the duration of the trial at CDSA.
Develop quality monitoring plan, SOPs, checklists and processes for clinical activities of data collection,
laboratory-based activities of sample processing and storage, and running of the biorepository.
Collaborate with clinical and project management teams to ensure compliance with quality standards, timelines, and appropriate followup in areas of deficiency.
Coordinate expert monitoring visits/ audits as per project requirements.
Work with the Clinical Portfolio Management department and other internal departments on their
requirements as and when required.
Work with data management and other key departments (laboratory, etc.) to track the process and progress and proactively ascertain the foreseen challenges.
Willingness to travel.
The selected candidates will work at our clinical site situated at Gurugram Civil Hospital.
Last date for receipt of online application: 19th May 2025
