Clinical Research Associate

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.
• Prepare site essential documents and support the ethics and regulatory submission and approval processes as needed.
• 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 plans and update as required.
• Monitor investigational sites as per ICH GCP5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study.
• 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.

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.
• Experience 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.

Requirements

• CRA II: 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).
• CRA III: Provide mentorship to junior staff and can also provide support to the line manager or project manager as per request.
• Senior CRA (SCRA): 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.
• Principal CRA (PCRA): Prepare, review, and deliver CRA training program modules and workshops in collaboration with Clinical Services Training team.

Skills

• Excellent communication and interpersonal skills.
• Strong organizational and time management skills.
• Ability to work independently and as part of a team.
• Proficient in Microsoft Office Suite and other relevant software.

Benefits

• Professional development opportunities.
• Competitive compensation package.
• Flexible work schedule.
• Health insurance benefits.

Pay

• Salary range based on experience and qualifications.

Schedule

• Full-time position.