Reports to: Director, Clinical Operations or other
Job Code: 2018-70-1
The Clinical Research Associate/Senior Research Associate will provide support for clinical trial operations including monitoring or co-monitoring of clinical trial sites, maintaining appropriate in-house clinical trial documentation and providing general support for the clinical development and regulatory activities of the Company. May be involved in various phases of development. Works under supervision.
- Independently conducts qualification, initiation, interim, close-out, and when warranted, co-monitoring visits. Assesses facility/staff, initiates protocols and ensures that all clinical aspects of trials are being carried out in accordance with the protocol and Good Clinical Practices (GCP)/International Conference of Harmonization (ICH) guidelines. Reviews site regulatory documents and maintains required study files
- Works with Principal Investigators and study staff, as appropriate, to ensure smooth operation and documentation of trials including but not limited to assessing site performance, tracking study drug and other study-specific material shipments to/from sites. Assures regulatory compliance of investigational sites with company SOPs, FDA, and ICH guidelines
- Documents monitoring visit observations in reports and letters. Resolves site-specific study issues by working with study staff and with CROs, as applicable. Monitors electronic data capture (EDC) systems including reviews for completeness and consistency. Generates and resolves queries in clinical data with clinical sites and/or through a CRO, ensuring proper reporting of Adverse Events and appropriate follow-up
- Contributes to the safety review process of ongoing clinical trials. Ensures proper reporting Adverse Events (AEs) and Serious Adverse Events (SAEs), coordinates presentation of information to Data Safety Monitoring Committees. Ensures timely notification to the appropriate Company and/or CRO clinical/regulatory staff and local IRB/IECs, as applicable.
- Assists with designing study documents including, but not limited to, case report forms, site study procedure manuals and source documents/worksheets, monitoring plans, tracking tools, and informed consent forms
- May provide monitoring guidance and support to contract CRAs in the field and in-house staff. May assess CRO activities related to site management, data management, and pharmacovigilance
- Supports clinical operations by ensuring trials are completed on time and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and ICH/GCP
- Complies with all applicable policies regarding health, safety, and environmental policies
- RN/BSN or BA/BS in life sciences or related area and 3-5+ years of experience in clinical trial monitoring/studies; or equivalent. BSN preferred. Oncology experience desired
- Must have on- site monitoring experience with a strong track record of effective on-site monitoring
- Demonstrated strong working knowledge and good use of judgment in application of FDA and ICH regulatory requirements
- Remarkable organizational skills. Must be detail oriented
- Strong problem solving skills; works proactively and effectively; identifies issues and problems and suggests solutions
- Excellent communication skills, including presentation and writing skills. Demonstrated positive interpersonal skills; ability to actively maintain good professional relationships with diplomacy and poise
- Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat and EDC systems
- Ability to travel ~-25%
GlycoMimetics, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter to HR@glycomimetics.com and reference job number 2018-70-1 in the subject line.