Covance is growing again in Mexico! This is an exciting opportunity to join one of the fastest growing parts of our business!
• Act as contact for project team and study sites.
• Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
• Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
• Assist with the management of study supplies and organize shipments.
• Create, update, track, and maintain study-specific trial management files, tools, and systems.
• Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings).
• Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
• Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
• Provide input in writing Monitoring Conventions as assigned.
• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
General On-Site Monitoring Responsibilities:
• Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).
• Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors.
• Perform other duties as assigned by management.
Covance is an equal opportunity employer and values diversity in the workplace. Your privacy and confidentiality are important to us (M/F/D/V)
*Responsibilities/Duties
• Act as contact for project team and study sites.
• Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
• Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
• Assist with the management of study supplies and organize shipments.
• Create, update, track, and maintain study-specific trial management files, tools, and systems.
• Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings).
• Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
• Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
• Provide input in writing Monitoring Conventions as assigned.
• Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
General On-Site Monitoring Responsibilities:
• Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).
• Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors.
• Perform other duties as assigned by management.
*Education/Qualifications
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
In lieu of the above requirement, candidates with one (1) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
*Experience
• Basic understanding of biology and biological processes.
• Good organizational and time management skills.
• Good communication skills, oral and written.
• Exhibit general computer literacy.
• Works efficiently and effectively in a matrix environment.
• Fluent in local office language and in English, both written and verbal.