Clinical Research Associate

The Clinical Research Associate will perform site activities for Phase I-IV studies operating as the main point of contact for the site during a study. Drive and execute monitoring plans, ensure site GCP compliance, write trip reports, resolve issues and facilitate open issue resolution, work on recruitment strategies, and monitor safety at the site.  The CRA  will conduct site qualification visits as assigned, site initiation visits and site training, routine monitoring visits, and site close-out visits. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).

Including but not limited to:

• Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner
• Knowledge of applicable SOPs, guidelines and study procedures
• Conduct study start-up activities related to in-house monitoring activities
• Assist with protocol and CRF review
• Complete study feasibility and site selection activities
• Conduct telephone screening interviews, administer site questionnaires, collect and review regulatory documents, assist with investigator grants negotiation
• Assist with investigator meeting activities including organization, preparation, and attendance
• Provide status of site activity to Project Manager
• Perform site management activities including but not limited to site qualification visit, site initiation visits, site training, site routine monitoring visit, and site close out visits
• Establish and maintain good rapport with study sites;a.maintain frequent telephone communication with sites, providing guidance to study coordinators and investigators as necessary and in agreement per monitoring plan
• Write study visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines
• Coordinate timely shipment of clinical supplies and study drug to sites in collaboration with regional CRAs
• Maintain adequate site tracking records
• Follow up of drug safety issues and safety reports in timely manner
• Communicate site study issues, concerns, and progress to Sr.CRA , Lead CRA, Project Manager and Clinical Operations Manager accordingly
• Assist with the implementation of corrective actions when appropriate
• Conduct in-house review of Case Report Forms
• Assist with data query resolution
• Perform telephone monitoring activities in order to obtain study status information
• Prepare/review all patient tracking records
• Input and maintain study information in tracking systems
• Provide information concerning subject status for financial reimbursement to sites
• Conduct and assist with administrative activities as a member of the project team;attend staff/project team meetings as required, document all investigator information and study contacts, assist with execution of investigator agreements and grant negotiations, prepare reports as defined by SOPs
• Ensure adherence to cost effective travel

Knowledge, Skills, and Abilities:

• Excellent verbal and written communication skills
• Good verbal and written English
• Strong computer literacy e.g. MS Word, Excel and PowerPoint
• Excellent organizational, record retention, and time management skills
• Excellent decision making skills
• Excellent customer service and interpersonal skills
• Knowledge of ICH-GCP, FDA & local regulatory requirements
• Ability to manage the sites independently.

Education and Work Experience:

• Bachelor's Degree in allied health fields such as Medical, Nursing, Pharmacy, or Health Science
• Minimum of 1-2 years in a related monitoring role within in clinical reasearch