Clinical Research Associate II - Oncology, Neurology, Ophthalmology; MN, WI, IN, MI, OH

Work Schedule

Standard (Mon-Fri)

Office

Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.).

Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects’ rights, well‑being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

• This is an opportunity for experienced CRAs with explicit on-site monitoring experience.
• Oncology, Neurology, and/or Ophthalmology therapeutic experience is highly preferred.
• Candidates must be located in the following states: MN, WI, IN, MI, OH (within 60 miles of the nearest major airport). Up to 80% travel is expected.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem‑solving skills to identify site process failures 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.
• Assesses 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 follows all issues through to resolution; maintains regular contact between monitoring visits with investigative sites to confirm protocol adherence, issue resolution, and timely data recording.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Collaborates with other project team members on issue/finding 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 and 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…