Clinical Research Associate II – Oncology, Neurology

This is a fully remote position, open to applicants in Colorado, +5 more states.

📋 Description

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

• Guarantees data integrity through the review of SDR, SDV, and CRF as required via on-site and remote monitoring efforts.

• Evaluates investigational products through both physical inventory assessments and records examination.

• Timely documents observations in reports and letters following approved business writing guidelines.

• Quickly 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, resolution of previously noted issues, and prompt data recording.

• Executes monitoring activities in alignment with the established monitoring plan.

• Engages in the investigator payment process.

• Shares responsibility with other project team members for resolving issues/findings, investigating and following up on findings as necessary.

• Attends investigator meetings as required, collaborating with the client company to identify potential investigators that meet the criteria for qualified investigative sites.

• Initiates clinical trial sites according to the relevant procedures to ensure adherence to protocol, regulatory, and ICH GCP obligations, providing recommendations as needed.

• Conducts trial closeouts and retrieves trial materials efficiently.

• Ensures that essential documents are complete and compliant with ICH-GCP and applicable regulations.

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

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

• Updates study systems in accordance with 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.

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

• Participates in additional project work and initiatives aimed at process improvement, as required.

⛳️ Requirements

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

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary to perform the job (approximately 1+ years as an on-site clinical research monitor) or completion of the PPD Drug Development Fellowship.

• Experience in Oncology and/or Neurology therapeutics is strongly preferred.

• A valid driver's license is required where applicable.

• Candidates must reside in the following states: WA, OR, ID, MT, WY, CO (within 60 miles of the nearest major airport).

• Up to 80% travel is anticipated.

🏝️ Benefits

• A selection of national medical and dental plans, alongside a national vision plan.

• A wellness program with valuable health incentive opportunities for company contributions to Health Reimbursement Accounts (HSAs) or Health Savings Accounts (HSA).

• Tax-advantaged savings and spending accounts as well as commuter benefits.

• Employee assistance programs.

• A minimum of 120 hours of paid time off (PTO).

• 10 paid holidays each year, as well as paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave).

• Accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy.

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