Clinical Research Associate

About the Role:

• Key role as a project manager would be Single Point of Contact (SPOC) for the Sponsor from Sterling Accuris Wellness Pvt. Ltd. for laboratory testing and the associate services for clinical trials.
• The role will require the ability to support the clinical trial study pipeline which could include various projects covering various therapeutic areas.
• The project manager would be responsible for setting up and executing clinical trial/study, ensuring compliance with the companys quality standards and regulations, forecasting timelines, milestones and budget.
• The project manager will work closely with the Technical Team and Operations Team for executing the clinical trials projects through regular meetings and giving feedback on study progress.
• The role will require the project manager to have an ethical leadership mind-set who would take personal accountability to use personal experience and knowledge as well as the training and tools provided by the company to maintain a good knowledge and understanding of all ethics and governance relevant for this role
• Escalating any decisions or seek support of team or management if personal knowledge and understanding is not at the level required to carry out any part of this role.

Key Responsibilities:

• Accountable for setting up activities according to the company standards, regulations in force and administrative timelines (setting up studies, preparing lab manuals, coordination of logistics, managing the supplies of consumables to research sites, maintaining data, etc.) and committed to targets and timelines are me at all steps and until study completion (recruitment, active/inactive sites, closure of sites, archiving).
• Ensuring the preparation of local study budgets within/across the countries, ensuring optimization of costs and managing the study budget.
• Ensuring the retention, storage and archival of reference laboratory data pertaining to clinical research activity in paper or digital format (as required by contract research organization).
• Visit the sterling accuris branches involved in clinical research activity periodically to ensure the compliance with regulation and contract research organization.
• Organizing kick-off meeting with local monitoring teams, training of teams (study procedures, site teams, reference laboratory staff) and investigator meetings
• Ensuring the implementation of study IT systems through company portals and adequate provisioning of devices and materials in advance.
• Handling and solving any concerns from contract research organizations and research sites.
• Facing audits from contract research organizations and regulatory bodies at reference laboratories.
• Overseeing field monitoring activities through regular contacts with the decentralized lab teams, reviewing, checking and monitoring the daily activities as per compliance
• Identifying potential problems/risks during/on-going of the study and ensuring the issues are solved with action plans (study conduct/data quality)
• Preparing customized study lab manuals as per protocol, test requisition forms, other essential documents, clinical study report, etc.
• Ensuring preparation and project response to audit/inspection reports and implementation of recommendations

Qualification and Skills

• BSc/MSc/B. Pharm/M. Pharm/Diploma in Clinical Research
• Minimum 2-5 years of experience in clinical research
• Knowledge of reference laboratory operations for clinical research activities
• Knowledge of clinical trial design and development in relevant therapeutic areas
• Ability to learn and apply SOPs
• Good IT skills essential for planning, tracking, communicating and reporting
• Management, leadership, communication skills, organizational, analytical and planning abilities, results oriented, proactive in anticipating and resolving conflicts/issues, time management