About the role
AI summarisedClinical Research Associate responsible for monitoring clinical trial sites, ensuring protocol and regulatory compliance, and managing documentation. The role involves risk-based monitoring, data verification, and collaboration with investigative sites and sponsors in the pharmaceutical/biotech industry.
Life SciencesFull-timeGeneral
Key Responsibilities
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
- Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assesses 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.
- May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
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 flexible 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.