Clinical Research Associate II – Oncology, Ophthalmology

This is a fully remote position, open to applicants in California.

📋 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 minimize risks. Verifies data accuracy through SDR, SDV, and CRF evaluations as necessary during both on-site and remote monitoring activities. Evaluates investigational products through physical inventory and record assessments. Records observations in reports and letters promptly, adhering to established business writing standards. Rapidly escalates identified deficiencies and concerns to clinical management and follows through to resolution. May require consistent communication between monitoring visits with investigative sites to confirm adherence to the protocol, resolution of previously identified issues, and timely data recording. Executes monitoring responsibilities in line with the approved monitoring plan. Engages in the investigator payment process. Shares accountability with other project team members regarding issue/findings resolution. Investigates and follows up on findings as necessary.

• Participates in investigator meetings as required. Collaborates with the client company to identify potential investigators, ensuring the acceptability of qualified investigative sites. Initiates clinical trial sites following relevant procedures to guarantee compliance with the protocol, regulatory, and ICH GCP obligations, providing recommendations as appropriate. Conducts trial closeout and retrieval of trial materials.

• Ensures that essential documents are complete and compliant with ICH-GCP and relevant regulations. Performs on-site file assessments according to project specifications.

• Supplies trial status tracking and progress update reports to the Clinical Team Manager (CTM) as necessary. Ensures that study systems are updated according to agreed study conventions (e.g., Clinical Trial Management System).

• Promotes effective communication between investigative sites, the client company, and the PPD project team through written, oral, and/or electronic interactions.

• Addresses company, client, and applicable regulatory requirements/audits/inspections.

• Completes administrative tasks such as expense reports and timesheets in a timely manner.

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

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

⛳️ Requirements

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

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

• Valid driver's license where applicable

• Proven skills in clinical monitoring

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

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

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

• Capability to manage Risk-Based Monitoring concepts and processes

• Excellent oral and written communication skills, with the ability to effectively engage with medical personnel

• Strong organizational and time management abilities

• Effective interpersonal skills

• Keen attention to detail

• Flexibility and adaptability in a variety of scenarios

• Ability to work collaboratively in a team or independently as needed

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

• Strong English language and grammar proficiency

• Competent presentation skills

🏝️ Benefits

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

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

• At least 120 hours of paid time off (PTO), 10 paid holidays per year, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

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

• Employees’ Stock Purchase Plan (ESPP) provides eligible colleagues the chance to buy company stock at a discount