Clinical Research Associate II – Oncology, Ophthalmology

📋 Description

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

• Guarantees data integrity through SDR, SDV, and CRF review as appropriate, conducted via both on-site and remote monitoring activities.

• Evaluates investigational products through physical inventory checks and examination of records.

• Records observations in reports and correspondence promptly, adhering to approved business writing standards.

• Expeditiously escalates identified deficiencies and issues to clinical management, ensuring all matters are followed through to resolution.

• Maintains regular communication with investigative sites between monitoring visits to verify adherence to protocols, address previously identified issues, and ensure timely data recording.

• Executes monitoring responsibilities in accordance with the sanctioned monitoring plan.

• Engages in the investigator payment process.

• Shares responsibility with other project team members in resolving issues and findings.

• Investigates and follows up on findings as needed.

• Participates in investigator meetings as required.

• Collaborates with the client company to identify potential investigators, ensuring the selection of qualified investigative sites.

• Initiates clinical trial sites in line with relevant procedures to guarantee compliance with protocols and regulatory as well as ICH GCP obligations, offering recommendations when necessary.

• Conducts trial closeout activities and retrieves trial materials.

• Ensures all essential documents are complete and properly filed in accordance with ICH-GCP and relevant regulations.

• Performs on-site file reviews as dictated by project specifications.

• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.

• Ensures study systems are updated in accordance with established 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 channels.

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

• Completes administrative tasks such as expense reports and timesheets promptly.

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

• Participates in other project initiatives and efforts for process improvement as required.

⛳️ 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 to perform the role (equivalent to 1 year as a clinical research monitor) or completion of the PPD Drug Development Fellowship.

• A valid driver's license where applicable.

• Demonstrated clinical monitoring competencies.

• Proven understanding of medical and therapeutic areas, along with medical terminology.

• Ability to acquire and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documentation.

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

• Proficient in managing Risk-Based Monitoring concepts and processes.

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

• Maintains customer focus through effective listening skills, attention to detail, and the ability to recognize underlying customer issues.

• Excellent organizational and time management skills.

• Strong interpersonal skills.

• Keen attention to detail.

• Ability to remain flexible and adaptable across various scenarios.

• Capable of working collaboratively in a team or independently as necessary.

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

• Proficient English language and grammar skills.

• Strong presentation abilities.

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan that includes health incentive programs.

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.

• A minimum of 120 hours of paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, as well as short- and long-term disability in accordance with company policy.

• Retirement and savings options, including our competitive 401(k) U.S. retirement savings plan.

• Employees’ Stock Purchase Plan (ESPP) allows eligible colleagues to purchase company stock at a discount.