MSN's client is seeking a Director of Clinical Operations for their Rockville, MD location. This position will manage and direct clinical operations, manage clinical research staff and ensure effective oversight and coordination of inpatient and outpatient clinical and translational research services. Additional responsibilities include oversight of the day- to – day operations, financial performance, regulatory compliance, strategic development, site management and monitoring of clinical and ...
We are looking for CRAs with at least 6 years monitoring experience and 3-4 years in Oncology . .
MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits). Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations. Maintains regular review of site regulatory binder and ensures proper storage, ...
Our client, a leader in the development and sales of nutritional and digestive health products is a high growth, high margin, specialty clinical nutrition company. Their products have been developed for patients with specific nutritional needs; patients who cannot eat, cannot eat sufficiently, or have a specific disorder. Known for excellence in its nutritional and digestive research capabilities, my client continually offers new, highly innovative products and services.
Some of the ...
Our CRO Client is looking for a full time / Permanent Sr Clinical Data Manager in either Chicago or Washington DC...MUST have industry related expereince
Manages the design, development, modification, and evaluation of systems for collecting and organizing clinical study data to identify, analyze, and report data and trends. Including but not limited to the development and design of case report forms; development of clinical data management plans; identifies and resolves data anomalies; over sees ...
CRAs - Join Covance and receive a $5000 Sign On Bonus!
Meet the CRA hiring team at the ACRP conference - email [email removed].
Set yourself up for SUCCESS with Early Clinical Development!
Now is the time to join our growing business where you have supportive management and a cohesive team.
At Covance, you are not just a number. We value you and your hard work...we want you to succeed.
URGENT Need for Oncology Monitors! Calling all Experienced Clinical Research Associates / CRAs / ...
We are looking for a Midwest CRA with Oncology and Infectious disease. Must have both therapeutic areas to be considered.
MONITORING – Preparation, conduct, and reporting of selection, initiation/startup, routine/interim and closeout monitoring visits, Site management, Assistance at internal and third-party audits). Assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol deviations. Maintains regular review of site regulatory binder and ...
Regulatory Medical Writer
Must have written all of the following: NDA submissions, Protocols, Narratives, Case Report Studies, and Inform Consent forms
Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical ...
We are just beginning a search for a Vice President of Quality (US Operations). Our client is a leading global health care company that focuses on medicines and medical devices used to care for critically and chronically ill patients. Our products include intravenous specialty and generic medicines, infusion therapies, blood-transfusion technologies and clinical nutrition.
The VP of Quality is responsible to assure that all activities associated with development, non-clinical and ...
- Looking for someone with Industry experiencing in actively running trials.
- An MD is preferred.
- Presumably someone with trial experience has the capability to triage SAEs.
- TA is immunology and is highly preferred.
- Board certification is not mandatory.
Provide medical leadership and strategic clinical program direction for the development of 4-5 indications in one or more new drug candidate programs.
The Medical Director assumes a leadership role in progressing ...
Assist Study Project Manager (SPM) for one or more clinical studies. Assist with management of Study Monitoring and Management (SM&M) and suppliers, such as CROs and Central Labs. Maxtrix management of functional area leads to meet study deliverables. Be aware of both internal and external business environments and their impact on studies. Escalate performance issues to management.
Assist SPM in the coordination of activities of cross-functional areas for the initiation, conduct and completion ...
Clinical Research Manager Associate
• Minimum of 3+ years of CRA experience or 3+ years related experience.
• Strong site management and monitoring skills • Experience in multi-therapeutic areas desired
• Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
• Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and/or federal regulations, and applicable local regulations.
Seeking experience with translational medicine, biomarker identification and companion diagnostics in the contect of Cancer therapeutics development to oversee operations and project management for globa pharmaceutical company.
Shall manage lab and clinical operataions including following activities:
*** Participate in the identification, selection and development of biomarkers and diagnostics for trials.
*** Manage, track and coordinate associated regulatory activities as well as lifecycle ...
Mar 7 -
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