Duties and Responsibilities (including but not limited to):
Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
Conduct study feasibility and site selection activities Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
Assist with investigator meeting activities including organization, preparation and attendance Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines. Establish and maintain good rapport with study sites.
Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines Representation of CRAs during an audit or inspection when assigned Coordinate timely shipment of clinical supplies and study drug to sites.
Ensure proper storage, dispensation and accountability of clinical supplies and study drug. Maintain adequate site tracking records Follow up of drug safety issues and safety reports in timely manner, if applicable Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead and Clinical Research Manager accordingly Develop and implementation of corrective actions when appropriate Assist with data query form (incl. query process) Prepare /review all patients tracking records Input and maintain study information concerning subject status of financial reimbursement to sites.
Conduct and assist with administrative activities as a member of the project team. Education and Work Experience: Bachelor’s Degree in allied health fields: Medical, Nursing, Pharmacy, Psychology, Veterinary or Health Science Minimum of 2 years experience as a Clinical Research Associate Knowledge, Skills, and Abilities: Excellent verbal and written communication skills Good verbal and written English language skills Strong computer literacy e.g.
MS word, Excel, PowerPoint, internet Excellent organizational, record retention, and time management skills Knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements.Duties and Responsibilities (including but not limited to):
Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
Conduct study feasibility and site selection activities Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
Assist with investigator meeting activities including organization, preparation and attendance Conduct site management activities including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines. Establish and maintain good rapport with study sites.
Write study visits reports and follow up letters within the timeline established by applicable SOPs and guidelines Representation of CRAs during an audit or inspection when assigned Coordinate timely shipment of clinical supplies and study drug to sites.
Ensure proper storage, dispensation and accountability of clinical supplies and study drug. Maintain adequate site tracking records Follow up of drug safety issues and safety reports in timely manner, if applicable Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead and Clinical Research Manager accordingly Develop and implementation of corrective actions when appropriate Assist with data query form (incl. query process) Prepare /review all patients tracking records Input and maintain study information concerning subject status of financial reimbursement to sites.
Conduct and assist with administrative activities as a member of the project team. Education and Work Experience: Bachelor’s Degree in allied health fields: Medical, Nursing, Pharmacy, Psychology, Veterinary or Health Science Minimum of 2 years experience as a Clinical Research Associate Knowledge, Skills, and Abilities: Excellent verbal and written communication skills Good verbal and written English language skills Strong computer literacy e.g.
MS word, Excel, PowerPoint, internet Excellent organizational, record retention, and time management skills Knowledge of ICH-GCP, applicable law (local and country) and regulatory requirements.