Job Number: 409244

Sr. CRA/CPM

Job Summary: 
Manage and oversee all aspects associated with clinical studies including protocol development, site selection/initiation, monitoring, study closeout, data management, and reporting.  Manage overall activities to ensure compliance with company standard operating procedures (SOPs), Food and Drug Agency (FDA) regulations, International Conference on Harmonisation (ICH) / Good Clinical Practice (GCP) guidelines, the study protocol and clinical objectives.  Travels to site 
to supervise and monitor clinical studies as needed.
Essential Functions:
1. Assist with the development of the Investigational Plan/Protocol and the ICF template and submit to central Institutional Review Board submissions as needed 
2. Ensure successful implementation of clinical initiatives Develop and manage clinical project timelines and budgets 
3. Manage study vendors; to include oversight of clinical supplies, CRO, data management groups, central IRB, central labs, and others.  
4. Develop data collection forms (CRFs) and other study tools for implementation and tracking of study activities 
5. Provide clinical data when needed for presentations, publications, and regulatory submissions 
6. Ensure that protocol-specific training for Investigators, Study Coordinators, and other key study personnel is conducted and documented. 
7. Communicate with sites regularly and resolve inquiries and problems related to clinical investigation 
8. Manage trial enrollment to meet timelines 
9. Obtain required legal, ethical and technical agreements with sites and vendors participating in studies   
10. Plan, organize, prepare materials for and participate in investigator meetings, ad hoc scientific advisory board meetings, or DSMB meetings, as required 
Additional Responsibilities:
1. Assist Director with regulatory submissions, such as IND safety reports and Clinical Study Reports 
2. Provide clinical data when needed for presentations, publications, and regulatory submissions  
3. Maintain a high level of professional expertise through familiarity with clinical literature and participation in project 
meetings 


Qualifications:
• Bachelor's degree, preferably in a Health- or Life Sciences-related field 
• Previous experience in the conduct of clinical studies, preferably in the Pharmaceutical or Contract Research Organization (CRO) industries;   
• Working knowledge of FDA and other regulatory requirements that may impact clinical studies; 
• Strong work ethic with excellent attention to detail and follow-through 
• Willingness and capability to handle multiple projects and responsibilities; 
• Excellent organizational, time management, and problem-solving skills;   
• Excellent written and verbal communication skills.   
• Effective business skills for interacting with peers and sites 
• Outstanding oral and written communication skills 
• Strong interpersonal skills 
• Experience in a supervisory role an asset 
• Comprehensive knowledge of Microsoft software (Word, Excel, PowerPoint, Project) 

Interested candidates please send resume in Word format to mklee@advancedclinical.com Please reference job code 409244 when responding to this ad.