Clinical Research Associate

**Minimum Qualifications & Experience**:
Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows:

- CRA I: Entry-level training position.
- CRA II: Approximately 1-2 years of Clinical Research Associate experience or equivalent experience (CRA II fast track) in other roles in the Clinical industry.
- CRA III: At least 2-3 years of Clinical Research Associate experience in the Clinical industry.
- Senior CRA (SCRA): At least 3-5 years of Clinical Research Associate experience in the Clinical industry.
- Principal CRA (PCRA): At least 5 years of Clinical Research Associate experience in the Clinical industry

**Responsibilities**:

- CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited and smooth management of clinical trials.
- Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines.
- In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
- In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
- Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
- Monitoring of investigational sites as per ICH GCP -5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
- Ensure the rights & wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are reported to the sponsor promptly.
- Verify trial data are accurate and complete, ensure CRF data and queries are completed and resolved as per the study timelines documented in the Clinical Monitoring Plan.
- Ensure all study drug is appropriately stored, dispensed, accounted for, and reconciled as per the Clinical Monitoring Plan and the Protocol.
- In collaboration with IHCRA or DMA team, ensure the project Trial Master File (TMF) is up to date, current and complete at all times throughout duration of the study.
- Support sites to be audit and inspection-ready at all times. Ensure all clinical trial management systems are current and up to date at all times with all relevant trial data.
- Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP.
- Collaborate with IHCRA and Site Contract Associates, as applicable, on-site payments, taking ultimate responsibility on site payments to ensure payment execution as per term stated in Clinical Trial Agreement.
- Assist the PM with the development of study related project plans and templates as per study requirements and support tasks as needed for successful study execution.
- Be aware of and adhere to company processes in areas relevant to a CRA. Be quality focused on the performance of duties. Assist in the review and development of clinical SOPs and processes.
- Participate in activities of the Clinical Services Department, including presentations at clinical department meetings, and assisting with the development of clinical processes and SOPs.
- In collaboration with Business Development (BD), foster relationships with sites to provide feasibility information, as requested, and in accordance with documented feasibility processes. Highlight any BD opportunities to the grou
- Understand the responsibilities of Novotech as a service provider in the pharmaceutical and biotech industry and ensure all communications with external and internal customers present a positive professional image of the company.

CRA II
- Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all ty