Job Details
Job Title: Clinical Research Associate (Part-Time)
Job Type: Part-Time (20 hours per week)
Experience: Minimum 2+ years of oncology monitoring experience required
Job Description:
- Conduct site evaluation visits, site initiation visits, interim monitoring visits, and close-out visits in accordance with study protocols, SOPs, and applicable regulations.
- Collaborate with Contract Research Organizations (CROs) and vendors to ensure efficient delivery of study materials and documentation to investigator sites.
- Ensure investigator sites comply with contractual and regulatory requirements for site initiation and study drug release.
- Assist in the development and implementation of study plans, including Monitoring Plans, Data Management Plans, and Safety Management Plans.
- Manage patient recruitment strategies, identify recruitment barriers, and propose solutions to enhance recruitment efforts.
- Monitor recruitment progress, data quality, and patient safety both on-site and remotely using Electronic Data Capture (EDC) systems.
- Liaise with study site personnel to ensure accurate and timely entry of data into electronic Case Report Forms (eCRFs) and resolve data queries promptly.
- Maintain project files and Trial Master File (TMF) documentation, including ethics committee approvals, investigator CVs, protocols, and other essential study documents.
- Handle Serious Adverse Events (SAEs) follow-up and ensure appropriate documentation and reporting.
- Assist with data coding, patient profile reviews, database lock activities, and site close-out procedures.
- Perform investigational product (IP) inventory, reconciliation, and ensure compliance with protocol requirements related to IP administration.
- Ensure timely and accurate submission of study documents to the TMF.
Skills and Qualifications:
- Bachelor's degree in life sciences or related field preferred.
- Minimum of 2+ years of clinical monitoring experience in oncology trials required.
- Proficiency in ICH-GCP guidelines and regulatory requirements.
- Strong communication, organizational, and problem-solving skills.
- Ability to work independently and efficiently in a remote or hybrid work environment.
- Detail-oriented with excellent time management skills.
- Proficiency in Microsoft Office Suite and familiarity with EDC systems.
Note: This position is part-time, requiring 20 hours per week. The exact schedule can be discussed during the interview process.