Senior Associate, Clinical Operations - Parsippany, NJ | Biospace
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Senior Associate, Clinical Operations

Ferring Pharmaceuticals, Inc.

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Location:
Parsippany, NJ
Posted Date:
7/26/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Clinical Operations, Clinical Research, CRA,

Job Description


Ferring Pharmaceuticals is a private, research-driven specialty biopharmaceutical company active in global markets. The company identifies, develops and markets 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 5,000 employees worldwide, it operates subsidiaries in over 60 countries and makes its products available in more than 100 countries.

The Ferring Philosophy places people at the heart of what we do. “people come first” guides our relations with patients, physicians employees, and other stakeholders. As a privately-held company with over 5000 employees worldwide, we invite you to share our passion for the power of people and science.

SUMMARY

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 schedule section for Vendors and process/obtain approval from management.
•   Assist the CRM as a lead CRA 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 trend 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.
•   Prepare 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 operation 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.

Requirements


REQUIRMENTS:

•   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 Project and Staff meetings (powerpoint)
•   Ability to make independent decisions for CRM back up.
•   Must possess strong technical skills and include a working knowledge of Microsoft Office.  

The above is intended to describe the essential job functions and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

We are proud to be an Affirmative Action/EEO Employer.  EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com