Senior Associate, Clinical Research
Location: Parsippany New Jersey
Description: Ferring Pharmaceuticals, Inc. is employing Senior Associate, Clinical Research right now, this job will be placed in New Jersey. Detailed specification about this job opportunity please give attention to these descriptions. Ferring Pharmaceuticals is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and mark! ets innovative products in the fields of endocrinology, gastroenterology, infertility, obstetrics, urology and osteoarthritis. In recent years Ferring has expanded beyond its traditional European base, with over 3,700 employees worldwide, it operates subsidiaries in over 45 countries and makes its products available in more than 70 countries.
Ferring US development organization of Ferring Pharmaceuticals, Ferring International Pharmascience Center U.S. Inc (FIPCUS), develops new groundbreaking medicine that can enhance the quality of life for people. To sustain this effort, we reward talent with influence. In return, we expect our employees to be people of ambition.
The Senior Clinical Research Associate (Sr CRA) participates in the conduct of single and multi-center clinical research studies, presents at monitor training meetings and investigator meetings, monitors recruitment and overall study progress, addresses issues as they arise within the realm of ! the Sr. CRA position, and makes decisions with the guidance of! the Clinical Research Manager (CRM). The Sr. CRA prepares study update reports and graphs. The Sr. CRA provides these functions for one or more studies simultaneously.
The Sr. CRA position serves as support to the CRM thought the conduct of the study. This individual will be required to have technical, leadership and interpersonal competencies. This position will assure compliance with Good Clinical Practices and FIPCUS policies and procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Participate in the planning of a study or multiple studies with the CRM.
- Perform operation and administrative duties assigned by the CRM.
- Assist with the CRO selection process and ensure contractual obligations are met.
- Assist the CRM with site study budget negotiations and payments.
- Assist CRM with Vendor identification and selection and payments vis a vis contractual agreements. Contribute to development of a payment sc! hedule section for Vendors and process/obtain approval from management.
- Assist the CRM as a leadCRA to study start up, study execution and close out activities.
- Assist in the development and coordination of protocols and informed consent forms.
- Assist in the planning and coordinating investigation meetings. Prepare and present protocol and general study-related presentation to field monitors, investigations and adequately informed of protocol requirements, standard operating procedures and monitoring procedures.
- Review data in the electronic data capture system; enter and reconcile queries as necessary. May also be involved in query resolution. Assist in trent review.
- Participate in the development of site reference materials.
- Monitor site preparation, including sending regulatory document packages to sites.
- Assist the sites in obtaining the required forms and passwords for all electronic systems.
- Prepa! re training materials related to monitoring practices and procedures to! be presented at monitor training meetings to ensure that the monitors are adequately informed of monitoring requirements and procedures.
- Review site qualification monitoring visit reports to assess site eligibility to participate in the study.
- Review monitoring reports throughout the study to ensure that sites are adhering to the protocol and to identify potential issues and propose solutions.
- Track and report on monitoring activities.
- Assist the CRM in CRO in vendor management, including independently holding meetings to identify and resolve issues. Maintain open lines of communication.
- Monitor ongoing progress of enrollment and other benchmarks at the investigative sites to assess adherence to the study protocol and timelines.
- Maintain FIPCUS internal tracking systems, including budgets and expenditures.
- Mentor CRA’s regarding regulatory accuracy and set-up of the Trial Master File.
- Perform operati! on and administrative duties assigned by the CRM.
- Mentoring junior CRAs
- Ensure that conduct of all studies follow local or global Ferring SOPs and regulatory requirements.
- A minimum of a bachelor's degree is required, preferably in a health or science related field. A RN or BSN is strongly preferred.
- A minimum of 5 years of experience in Clinical Research is required. Global experience is a plus.
- Must have experience with site qualification, initiation, regular monitoring and site close-out visits.
- Demonstrates an understanding of regulatory requirements including a working knowledge of FDA GCP and ICH guidelines.
- Must have knowledge of EDC system.
- Must have good written and verbal skills to communicate effectively with investigators and departmental personnel about protocol related topics. Must be able to present reports and updates at Projetc and Staff meetings (powerpo! int)
- Ability to make independent decisions for CRM back up.
- Must possess strong technical skills and include a working knowledge of Microsoft Office.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Ferring Pharmaceuticals, Inc..
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This job starts available on: Sun, 07 Apr 2013 05:45:09 GMT
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