- Roles and responsibility:
Manage & monitor approximately 6 to 8 sites in multicentre clinical trial
Ensuring site level compliance & adherence to regulatory requirement protocol & SOPs
Coordinating with external vendors & internal team members for the smooth execution of the study
Maintaining study level & site level regulatory & study documents
Acting as a main point of contact between investigator & CRO to manage site level activities.
Conduct site study team trainings for GCP & study specific procedures
Detailed description of MAIN tasks and responsibility:
Conduct feasibility assessment for the study
Participate in the identification of potential investigators and clinical sites
Prepare confidentiality agreement with the investigator
Prepare the clinical trial agreements.
Assist in the identification of centralized services such as clinical laboratories.
Assist with the development and implementation of study specific monitoring, reporting procedures and subject tracking systems
Conduct Site selection / Lab selection for investigational site and laboratories
Participate and / conduct site meetings and multicenter investigator meetings and prepare reports.
Setting up the study centers, by ensuring each centre has proper training of all participants, adequate materials and ensure that the investigator knows exactly what has to be done.
Collate documents for Ethics committee submissions.
Ensure that investigators obtain EC approval before initiating the sites.
Conduct initiation visits, monitoring visits and study closure visits to assess compliance to the protocol, regulatory requirements and adequate documentation and prepare visit reports.
Verify that the trial related duties are performed only by authorized personnel and that the trial related information is accessed only by authorized personnel.
Review on-site files and records, case report forms and source documents for completeness, accuracy, consistency and compliance, identifies deficiencies and discrepancies and provides remedial training and / or initiates corrective action as required.
Verify that the investigator provides all the required reports, notifications, applications and submissions are timely, accurate, legible and complete and dated.
Ensure compliance to the trial protocol and regulatory requirements by reviewing study documents and procedures on site.
Ensure all used and unused trial supplies are accounted for.
Ensure appropriate safety reporting of SAE and AE.
Ensure appropriate transmission of CRF to the data management centers / source data verification in case of e-CRF. Review case report queries and problems and clarifies and / or obtains changes to data as appropriate.
Verify the recruitment rate and check for any follow up problems.
Motivate investigators in order to achieve recruitment targets.
Filing and collating trial documents and reports.
Assemble necessary documents; conduct site closure / termination visits to include investigational product reconciliation and disposition, review for completeness and accuracy of files, retrieval of relevant codes and documents. Assess suitability of archival facility and prepare study termination reports.
Prepare Standard Operating Procedures and study specific Working Documents as and when required.
Intimate & coordinate the pharmacist for dispensing of Investigational Product to sites.
Skills/Qualifications:
Communication & time management
MS office & presentations skills
Team work & Interpersonal skills
Willingness to travel at least 70% of the time & simultaneously coordinate for in-house activities.
2 to 3 years of experience with minimum of 1 year multicenter study monitoring including initiation & close out
Must have clinical data management coordination experience in achieving database lock
Graduation / Post Graduation in Life sciences, Pharmacy, Nursing & Paramedical.
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