Clinical Research Associate

Job Description

The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Client SOPs.

• Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure 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.
• Prepare site essential documents and support ethics and regulatory submission and approval processes in collaboration with the In‑house Clinical Research Associate (IHCRA) and Regulatory Start‑Up Associate (RSA).
• Understand requirements of applicable local and international regulatory authorities.
• Ensure recruitment of participants as per the site target; drive site recruitment and engagement initiatives; prepare and update site‑specific recruitment plans.
• Monitor investigational sites as per ICH GCP 5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. Includes all monitoring visit types across all phases of a clinical trial, including Site Selection, Site Initiation, Site Monitoring, Site Close Out, unblinded pharmacy visits, and co‑monitoring visits. Visits can be conducted either onsite or remote as per CMP.
• Ensure the rights and wellbeing of trial participants are protected, including consent form checks, patient eligibility confirmation, protocol compliance, investigational drug compliance, and review of Adverse Events/SAEs; report safety issues 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.

• Graduate in a clinical or life sciences‑related field.
• Good time management skills, attention to detail, ability to work well in a team, and computer literacy.
• Preferably experience of working in the research, pharmaceutical industry or a related field as per job level below.
• Experience or qualifications in allied professions may also be considered.

• CRA I: Entry‑level training position.
• CRA II: Approximately 1‑2 years of Clinical Research Associate experience or equivalent experience in other roles in the Clinical industry. Responsibilities:
• Responsible for learning the company culture, policies, and procedures through specialized training called CRA II fast track training program including observational visits for all types of visits (if applicable) and on‑job training by supporting the day‑to‑day CRA activities of clinical project team members such as CRAs and Line managers (LMs).
• Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
• CRA III: At least 2‑3 years of CRA experience. Responsibilities:
• Provide mentorship to junior staff and can also provide support to the line manager or project manager as per request.
• Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
• Senior CRA (SCRA): At least 3‑5 years of CRA experience. Responsibilities:
• Provide mentorship to junior staff and can also provide support to the line manager or project manager in the role of Lead Clinical Research Associate.
• Provide the support on ad‑hoc visits and can be assigned to evaluate and assess junior CRA staff as…