Clinical Research Associate II

📋 Description

• Oversees investigator sites utilizing a risk-based monitoring strategy: employs root cause analysis (RCA), critical thinking, and problem-solving abilities to pinpoint failures in site processes and implement corrective/preventive measures to ensure compliance and mitigate risks.

• Guarantees data precision through SDR, SDV, and CRF evaluations as necessary via both on-site and remote monitoring efforts.

• Evaluates investigational products through physical inventory checks and records assessments.

• Timely documents observations in reports and correspondence adhering to approved business writing standards.

• Promptly escalates identified deficiencies and issues to clinical management and ensures all matters are addressed until resolved.

• May require maintaining regular communication with investigative sites between monitoring visits to verify adherence to protocols, confirm resolution of previously noted issues, and ensure timely data recording.

• Conducts monitoring activities in accordance with the established monitoring plan.

• Involved in the investigator payment process.

• Shares responsibility with other project team members for the resolution of issues/findings.

• Investigates and follows up on findings as needed.

• Participates in investigator meetings as required.

• Collaborates with the client company to identify potential investigators and ensure the acceptability of qualified investigative sites.

• Initiates clinical trial sites following relevant procedures to ensure adherence to the protocol and regulatory and ICH GCP obligations, making recommendations as appropriate.

• Conducts trial close-out and retrieval of trial materials.

• Ensures completion and availability of essential documents in compliance with ICH-GCP and applicable regulations.

• Executes on-site file reviews according to project specifications.

• Provides trial status tracking and progress updates to the Clinical Team Manager (CTM) as necessary.

• Ensures study systems are updated according to agreed study conventions (e.g., Clinical Trial Management System).

• Facilitates effective communication among investigative sites, the client company, and the PPD project team through written, oral, and/or electronic means.

• Responds to company, client, and relevant regulatory requirements/audits/inspections.

• Maintains and completes administrative tasks, such as expense reports and timesheets, in a timely manner.

• Contributes to the project team by assisting in the preparation of project publications/tools and sharing ideas/suggestions with team members.

• Engages in additional project work and initiatives for process enhancement as needed.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (equivalent to 1 year as a clinical research monitor) or completion of the PPD Drug Development Fellowship.

• Valid driver's license where applicable.

• Proven clinical monitoring capabilities.

• Demonstrated comprehension of medical/therapeutic area knowledge and medical terminology.

• Proven ability to acquire and maintain a working knowledge of ICH GCPs, relevant regulations, and procedural documents.

• Well-honed critical thinking skills, including but not limited to: a critical mindset, thorough investigation for appropriate root cause analysis, and problem-solving.

• Ability to manage Risk-Based Monitoring concepts and processes.

• Strong oral and written communication skills, with the capability to effectively engage with medical personnel.

• Ability to uphold customer focus through good listening skills, attention to detail, and the ability to recognize underlying customer issues.

• Excellent organizational and time management abilities.

• Effective interpersonal skills.

• Strong attention to detail.

• Capacity to remain flexible and adaptable across a variety of scenarios.

• Ability to work collaboratively in a team or independently as required.

• Proficient computer skills: solid knowledge of Microsoft Office and the ability to learn relevant software.

• Strong English language and grammar proficiency.

• Good presentation skills.

🏝️ Benefits

• Opportunities for professional development.