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Location: Northern US
***IMPORTANT*** You must CLEARLY indicate the CITY, STATE for each candidate in the Supplier Comments section of the submitted AND at the top of every resume. Do not provide the candidate's entire address or contact information.
Regional Site Managers (CRAs) to support the goals of the GenMed organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Client SOPs and ensuring that study milestones are met. Central point of communication between Client and investigational sites for all GenMed clinical trial related activities.
• Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
• Ensure the site Investigator Folder is up to date and mirrors the Client TMF. Responsible for collecting regulatory documents from site and filing in the Client TMF. Prepare and collect study site documents.
• Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism.
• Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in conjunction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues.
• Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return.
• Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems.
• Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).
• Enforce and follow GCP and ICH requirements as appropriate.
• Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations. May review and approve monitoring reports of junior CRAs as assigned.
• Manage data query resolution process with sites and track status updates (i.e. IWS).
• Perform Site Closeout activities per SOPs and applicable regulations.
• Travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
***A minimum of 50% overnight travel may be required***
• Attend and participate in disease indication and project specific training and general CRA training as required.
• Minimum of 3-5 years of experience as a CRA.
• Solid medical and business knowledge.
• Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.
• Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations.
• Excellent oral and written communication and presentation skills.
• Computer literacy and proficiency.
• Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.
Bachelor’s degree or higher in a scientific or healthcare discipline preferred. A nursing degree or extensive relevant experience may commensurate
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