Clinical Research Associate
Job Code: 3510608.1MB

We are seeking a reliable, self-motivated clinical research professional
who is able to work both independently and within a team environment.
The primary role of the position is to assist with the coordination and
activities of the clinical development team and will report directly to
a Clinical Trials Manager.

Responsibilities include

• assisting in the development of the following: Clinical Study Protocols, Case Report Forms (CRFs),Model Informed Consent Forms, Study Guidelines, Monitoring Plans, Clinical Development SOPs, Clinical Safety Reports;
• assisting with the design and planning of clinical research projects;
• creating and maintain tracking tools and status reports;
• assisting in the identification and selection of clinical investigators. This includes conducting investigator and site evaluation meetings;
• assisting with the following site start-up activities; * developing and negotiating study budgets; * collecting essential regulatory documents required for release of investigational product to the site. Ensuring all required regulatory documents are ICH/GCP-compliant; * conducting clinical site initiation meetings;
• performing the following clinical trial monitoring tasks * reviewing source documents and verify completed CRFs; * working with CROs and investigators to ensure compliance to ICH/GCP, protocols and overall clinical study objectives; * performing ongoing review and collection of regulatory documents; * performing investigational product accountability and reconciliation; * maintaining contact with sites for study-specific issue resolution and ensure appropriate documentation of all site and protocol related issues; * co-monitoring with CRO's as needed. Travel is typically required 20-35% (occasionally up to 50%) of the time; * reviewing CRO monitoring trip report and letters;
• monitor the progress of studies. Identifying delays and initiate corrective actions when necessary;
• administering study budgets;
• assisting with vendor selection and management;
• ensuring adherence, in collaboration with CROs, to reporting requirements for SAEs;
• assisting, in collaboration with CROs, with the following data management tasks; * resolving CRF data queries; * preparing CRFs for data entry; * verifying database consistency and accuracy;
• participating in project team meetings; and
• enhancing expertise through familiarity with clinical and scientific literature and participation in professional activities.

Requirements:
BS/BA in biological sciences or related field or RN. At least 3+ years
related experience in life science, including at least two years
experience as a CRA in the biopharmaceutical industry. Familiarity with
GCP/ICH guidelines. Familiarity with pharmaceutical and medical
terminology. Excellent organizational skills. Able to execute multiple
tasks in a fast-paced, changing environment. Excellent communication
skills. Strong teamwork and leadership skills. Must be proactive and
assertive. Strong attention to detail. Constructive approach to problem
solving while dealing with time demands, incomplete information or
unexpected events. Ability to influence investigators and investigative
staff in a positive manner.

Computer proficiency in Microsoft Word, Excel and PowerPoint. Experience with
development and administration of site budgets and grants with
supervision.