Clinical Research Associate

About the role

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.

Responsibilities

• 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 GCP5.18 (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.

Minimum Qualifications

• Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in Allied Professions may also be considered.
• 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 per job level as follows:

Experience levels

• 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. 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 the 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 Clinical Research Associate experience in the Clinical industry. 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 Clinical Research Associate experience in the Clinical industry. 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 needed. Participate in activities of the Clinical Services department, including presenting at clinical department meetings, assisting with the development of clinical processes and SOPs. Identify areas of inefficiency in processes and make recommendations for improvements.
• Principal CRA (PCRA): At least 5 years of Clinical Research Associate experience in the Clinical industry. Prepare, review, and deliver CRA training program modules and workshops in collaboration with Clinical Services Training team. Act as LCRA on assigned projects according to study-specific, documented delegation. Possible tasks are outlined in the LCRA Role Description. As a PCRA a high degree of delegation from the PM is expected especially regarding mentoring and matrix management of CRA's and championing processes with the team. Serve as a back-up line manager or formal mentor to assigned CRAs and IHCRAs; Conduct co-monitoring visits, solo signoffs, and assessment visits as required. Assume project management responsibilities, i.e., serve as back-up PM, where appropriate, under the supervision of a Project Manager or Line Manager.