About the role
AI summarisedThe Clinical Research Associate I role involves monitoring investigator sites to ensure protocol and regulatory compliance, managing documentation, and supporting clinical trial execution across global sites. Responsibilities include conducting on-site and remote visits, verifying data accuracy, managing investigational products, and maintaining communication with sponsors, sites, and internal teams. The role requires a life sciences or nursing background, foundational clinical monitoring experience, and strong organizational, communication, and analytical skills.
Life SciencesOnsite
Key Responsibilities
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
- Assess investigational product through physical inventory and records review
- Documents observations in reports and letters in a timely manner using approved business writing standards
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution
- May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner
- Conducts monitoring tasks in accordance with the approved monitoring plan
- Participates in the investigator payment process
- Ensures a shared responsibility with other project team members on issues/findings resolution
- Investigates and follows-up on findings as applicable
- Participates in investigator meetings as necessary
Requirements
- Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
- Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered
- Valid driver's license where applicable
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Good interpersonal skills
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
- Good organizational and time management skills
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills