Kalai Arasi

• Manages a team of 31 employees in FSP team.
• Participate in the selection and onboarding process for new staff by conducting candidate review and participating in the interviewing process.
• Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs. Ensure that staff have the proper materials, systems access, and training to complete job responsibilities. Provide oversight for the execution of the training plan, Standard Operating Procedures (SOP) review, and mentored training experiences, as applicable.
• Participate in the allocation of resources to projects by assigning staff that are appropriate to their experience and training.
• Manage the quality of assigned staff & work through regular review and evaluation of work product.
• Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by Records Management.
• Manage staff in accordance with organization’s policies and applicable regulations.
• Responsibilities include planning, assigning, and directing work appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems and approve actions on human resources matters.

Managed a global, multi-center, phase II oncology trial.

Responsibilities include:

• Identification of potential investigational sites and oversight the site evaluation process
• Creation of study manuals, procedures, and documents
• UAT testing for eCRFs
• Streamlining processes between multiple clinical trials
• Managing the team which performs SIVs and protocol training for vendors and sites as needed
• Review & sign off study reports
• Oversight on the team of negotiating site budgets and facilitating contract negotiations
• Providing final review of ICFs prior to ethics committee submission and responding to ethics committee protocol questions
• Vendor oversight including CROs, imaging, central lab, and EDC vendors as a Project integration manager.
• Conducting site and vendor audits
• Addressing escalated site & study issues
• Working closely with Patient Support Services at a global level to ensure proper communication between the clinical and field teams
• Facilitating recruitment efforts by coordinating/planning Investigator Meetings, review of the study newsletter, face to face meetings with investigators and creating recruitment plans on a site by site and study level

• Coordinate and supervise the activities of clinical team members engaged in the project.
• Organize and assign duties and tasks to clinical team members.
• Establish clinical team member work schedules monthly and establish provider schedules monthly.
• Monitor daily performance of clinical team members to ensure duties are completed accurately, efficiently and timely. Monitor and control overtime.
• Evaluate performance of clinical team members and conduct verbal and written performance evaluations after 30 days, 90 days and annually as needed.
• Assist with interviews. Conduct orientation and training on clinical policies and procedures.
• Identify and recommend solutions to clinical team member and office issues or problems.
• Maintain and provide oversight on the team of CRAs, CMLs, SRS and CTAs.

• Manage team of 20 (different roles like Remote monitors and Clinical Analyst support globally) and providing continuous oversight to achieve Project deliverables for a oncology phase 2 study. Establishing and maintaining effective project communication with CPM and coordination with clients for remote monitoring concepts and overall project deliverables globally across US/Canada, EU, Middle East and APAC countries.
• Forecasting budgeting and EAC for the functional team throughout the project lifecycle.
• Participating in Investigator Meetings and Project kick off meetings to endorse Risk based monitoring and project key inputs.
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans such as Clinical Operations plan, Escalation plan, Vendor Management plan, Remote monitoring process guide (at department level as well as project level) and work instructions.
• Review, evaluate and recommend modifications to designated processes in an ongoing way.
• Participating in study team meetings and internally and study analytical meeting with client on a weekly basis.
• Acting as point of contact for assigned deliverables for specific customers or projects for Remote Monitoring.
• Continuous evaluation of quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Performed initiatives such as preparation of training plans for Central Monitors and Centralized monitoring lead roles and Process guides.
• Conducted various trainings for new hires and developed training tools, training and project dashboards.
• Developed Project metrics tool specifically for the current project which is in use by the Project stakeholders.
• Assisting Clinical operations team to maintain good compliance throughout the study period and especially during DBL and close out phase.

• Ensure accurate completion and maintenance of internal systems, databases, tracking tools for the project specific information.
• Performed Management of triggers and preparation of i-site pack for respective sites and countries for assigned studies.
• Assisted in developing required basic data analytics scope and performing the trend analytics for their respective studies.
• Participated in (study) team meetings and interacted with cross functional staff to verify information and/or triage new data issues or prior identified action items
• Escalated quality issues pertaining to site to respective Centralized monitoring lead.
• Performed Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion & exclusion criteria/ IP/AE/ Labs/EOT/EOS/ End points/SAEs etc.) Review any other information as necessary to determine overall readiness of the patient information for next level review

• Taking care of the recruitment for phase one trials.
• Identify and assess the suitability of facilities to use as the clinical trial site.
• Liaise with doctors, consultants or investigators on conducting the trial
• Set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP), access management for required systems etc.
• Train the site staff to trial-specific industry standards.
• Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
• Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collect completed CRFs from hospitals and general practices
• Write visit reports and file and collate trial documentation and reports
• Meet with team members to discuss on-going trials, results and any trends or adverse events
• Ensure all unused trial supplies are accounted for
• Close down trial sites on completion of the trial