Title: Sr. Clinical Research Associate
Company: Medical Device
Location: Northfield, IL | Open To Relocators
Notes: No Corp to Corp
Conduct and manage clinical trials independently with minimal guidance from Manager/AD in accordance with ICH (International Committee for Harmonization), GCP (Good Clinical Practices) guidelines, and company's SOPs (Standard Operating Procedures.
Engage in clinical research projects to ensure compliance with protocols, regulations, and overall clinical objectives.
Assist Manager by leading and mentoring other Clinical Operations staff and guide or initiate department process improvements.
- Responsibilities:Able to explain the disease process or condition and associated products that are used in assigned clinical study and is able to summarize drug/device classifications. Can discuss and recognize alternative treatments and evaluates the risk/benefits as able and understand Standard of Care.. Can provide staff project related training as requested/needed on these topics.
- Able to define the different phases of product development, key protocol sections, critical process and data, areas of risk. Can explain research methodology and primary/secondary endpoint(s) along with the rationale for complying with clinical study procedures. Works closely with Medical Communications group and will escalate protocol design questions to project team and identifies risks associated with trial design such as key protocol sections, endpoints, etc. Guides the development and completion of trial related or regulatory documents with CRA I and CRA II. Serves as resource and mentor on project tool development and content as needed.
- Explains elements of subject safety including privacy protection, informed consent, reasoning behind use of IRB/EC, study activity documentation, and eventreporting requirements and is able to review for potential scenarios where these may be compromised. Recognize and report situations requiring prompt escalation. Performs root cause analysis and implements preventive and corrective actions. Can perform some basic trending analysis and identify opportunities for improvements
- Completes and documents organizational and project related training within defined timelines in compliance with applicable Medline Industries, Inc., ICH/GCP, local and ISO regulations and requirements. Seeks additional training options internally and externally. Can facilitate presentations of external information to the team. Serves as basic content subject matter expert for general research processes and general regulatory information and stays current with industry changes in those areas. Mentors junior staff with all aspects of the CRA role.
- Demonstrates working knowledge of GCP guidelines; identifies and reports/escalates non-compliance; predicts possible non-compliance based on study and site complexities and manages risks as part of a risk management strategy. In addition to managing assigned site issues with limited assistance from Manager or AD, will assist CRA I and CRAII with developing any training or corrective plan for areas of non-compliance or issue resolution and will assist them with any site training/retraining as needed. Can assist with issue trend analysis.
- Plans and conducts all types of monitoring visits to confirm Investigator/site compliance with ICH/GCP, FDA Code of Federal Regulations (CFR), or other requirements; assess site capabilities, resources, and Investigator/staff qualifications; assess adequacy of approval or notifications to IRB or ECs and/or Regulatory authorities; confirm recruitment, enrollment and subject participation strategies; confirm protocol adherence; confirm appropriate product management and accountability; confirm subject privacy, protection, and safety; identify and confirm appropriate management of safety events; confirm essential document management including document archival; assess issue identification, resolution and CAPA creation; identify and reportrisk, non-compliance, or misconduct, and facilitate corrective action; confirm appropriate study sample management. Tactfully discusses and manages concerns with site staff and provides follow-up as indicated - escalates issues appropriately. Provides support to junior CRAs on collecting information and discussing concerns with site staff. Can oversee "see one" and "do one" monitoring visits.
- Performs data review in identified site source and verification in applicable clinical systems to confirm data integrity, and identify and mitigate potential issues and risks; Confirms site compliance with Electronic Record Requirements and Regulations; Works appropriately within any clinical systems to write clear, concise and directed queries that comply with ICH/GCP and works with site staff to facilitate effective resolution and timeline compliance; Reviews site systems and assesses compliance with ICH/GCP and verifies system access is controlled. Demonstrates competency with clinical trial systems use and adheres to project metrics and timelines. Assists with staff training on systems use and develops tools as needed. Identifies project specific trends or issues and escalates appropriately as well as recommends solutions to address the issues.
- Requirements:Bachelor's degree in a life science (ex. biology, biomedical, nursing, microbiology, psychology).
- At least 5 years of experience working on clinical trials to include: following clinical protocol; study report writing; and monitoring activities in accordance with GCP (Good Clinical Practices) and ICH (International Committee for Harmonization) Guidelines.
- Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
- Experience assessing and responding productively to change in a timely manner.
- Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
- Advanced level skill in Microsoft Word (for example: adding developer tab, creating a macro, formatting table style, inserting comments and/or creating a mail merge).
- Willing to travel up to 80% of the time domestically or international with overnight stays.
- Experience in electronic clinical trial systems such as CTMS, EDC, and eTMF
- International study experience
- Mentoring and staff leadership skills
- Experience in Medical device industry
- CRA, or CCRP certification as granted by ACRP (Association of Clinical Research Professionals), SOCRA (Society of Clinical Research Associates), or equivalent research industry or academic certification is preferred.
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