Clinical Research Associate

Job Description :

Key Responsibilities:

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals,

recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution. May support the start-up phase.

• Exploits available hardware and software to support the effective conduct of the clinical project data review and capture
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File

(TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Coordinate end-to-end cross-functional project operations and multi-disciplinary activities to ensure that project deliverables are met
• Monitor progress of project activities and deliver frequent updates to the Clinical Project Manager.
• Involved in coordination with legal team to prepare and review and/or to execute agreements with investigators and vendors (Master service and/or amendment, CDA, NDA)
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting the development of project, and subject recruitment plan on a per site basis.
• Negotiates investigator remuneration; prepares financial contracts between COD-Research and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites. If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirements.

Qualifications :

• Bachelor’s Degree in scientific discipline or health care preferred.
• At least 2-3 years of independent on-site monitoring experience.
• Experience in all types of monitoring visits in Phase II and/or III (Oncology Preferred)
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills include proficiency in using Microsoft Word, Excel and PowerPoint and using a laptop computer.
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Ability to travel domestically as needed to study sites and for training and meetings.
• A minimum of 50% overnight travel may be required