Clinical Project Associate - Merz North America, Inc
Raleigh, NC 27601
About the Job
Supports the coordination of Merz sponsored clinical trials to ensure quality and adherence to regulatory requirements.
Essential Duties and Responsibilities
- Coordination of clinical trials:
- Support internal operational tasks related to clinical trial conduct
- Provide vendor oversight of specific operational tasks
- Coordinate site feasibility questionnaires
- Coordinate provision of investigational product and trial-specific supplies
- Support submission to Institutional Review Boards (IRBs)
- Support qualification and training of external providers and clinical trial sites
- Enter status updates into internal trial database
- Preparation and review of documents:
- Support preparation of trial-specific documents, (e.g., Informed Consent Forms training documents, manuals and plans, Clinical Study Report appendices)
- Perform in-process control checks on operational level (e.g., QC checks)
- Contract and budget management:
- Support preparation of vendor request for proposals, vendor contracts/change orders, and investigator agreements, including collaboration with vendors, legal and sourcing departments
- Set up purchase orders in Ariba
- Complete internal reporting of payments to health professionals according to legal requirement (e.g., Sunshine Act)
- Document management:
- Maintain Trial Master File (TMF/eTMF)
- Ensure readiness of TMF for audit/inspection
- Prepare TMF/eTMF for long-term archiving
- Meeting management:
- Set-up and attend trial-related meetings
- Support trial team meetings, including agendas and minutes
- Quality oversight:
- Support adherence with internal SOPs and relevant regulatory requirements
- Support audits and professional management of CAPAs in collaboration with involved functions
- Other duties as assigned:
- Minimal travel as required
Job Related Qualifications/Skills
Professional Experience
- Required:
- Experience in coordinating and conducting clinical trial tasks (>3 years) as a clinical project associate and/or in other areas of clinical research
- Experience in clinical study processes
- Experience in electronic trial master file (eTMF)
- Preferred:
- Experience with vendor contracting, set-up and oversight
Knowledge, Skills, and Abilities
- Required:
- Knowledge in clinical research and in the conduct of clinical trials
- Knowledge in relevant regulations (ICH GCP, EU CTR, MDR, FDA, etc.)
- Good verbal, written communication and presentation skills
- Preferred:
- Knowledge of medical or scientific terminology
Education
- Required:
- Bachelor degree in life sciences or medical health or other comparable professional qualifications
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Research and Development
Source : Merz North America, Inc