Clinical Research Associate II – Oncology, Neurology

Role Overview

• 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.
• Assess 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. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
• Contributes to 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 and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1+ years as an on-site clinical research monitor) or completion of PPD Drug Development Fellowship.
• Oncology and/or Neurology therapeutic experience is highly preferred.
• Valid driver's license where applicable.
• Candidates must be located in the following states: WA, OR, ID, MT, WY, CO (within 60 miles of the nearest major airport).
• Up to 80% travel is expected.

Tech Stack

• Google Cloud Platform

Benefits

• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance programs
• At least 120 hours 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, short
• and long-term disability, and volunteer time off in accordance with company policy.
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan