Senior Clinical Research Associate (Sr CRA)

Thermo Fisher Scientific Inc

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 Senior Clinical Research Associate, you'll conduct on-site or remote 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 and client company personnel. You may assist the project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

Key Responsibilities

• Support the Clinical Operations team in the region with the CRO setup and obtention of required licenses.
• Support study teams as a Subject Matter Expert on different aspects of feasibility, submissions, contract negotiations and startup activities (e.g., Tracking RFPs, Site identification, Advice during EC/RA Submissions).
• Participate with the local team to customize monitoring plans, operational procedures and tools to ensure accurate approach and adherence to local regulations.
• Collaborate with cross-functional teams to successfully implement study plans and resolve any issues that arise.
• Strictly maintain all documentation and records according to company and regulatory standards.
• Provide guidance and mentorship to junior CRAs, encouraging a culture of inclusion and continuous improvement.

What You ll Do:

• 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
• Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Lead.
• 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. Ensures 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.
• Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share potential solutions for improvements.
• Performs additional tasks as assigned by Clinical Lead or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• Provides trial status tracking and progress update reports to the Clinical Lead as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.
• 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 federal regulatory requirements/audits.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner