Sr. Associate, Clinical Research | BioNJ Talent Services

Sr. Associate, Clinical Research

Contact Information
Contact Name: 
Ferring Pharmaceuticals
Organization Name: 
Ferring Pharmaceuticals
Position Location: 
Parsippany
Company Profile: 

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology) and orthopaedics. Ferring’s US operations employ approximately 800 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Job Description:

Summary:

The Sr. CRA position serves as support to the CRM thought the conduct of the study. To deliver value and efficiency to ensure all clinical trials and projects are delivered within the of assigned projects scope, time, and budget.

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. Perform operation and administrative duties assigned by the CRM. Ensure that conduct of all studies follow local or global Ferring SOPs and regulatory requirements.
•Mentor CRA’s regarding regulatory accuracy and set-up of the Trial Master File. Mentoring junior CRAs

Qualifications: 

Requirements:

•Degree educated (Life Science) or 10 years of relevant clinical research experience in pharmaceutical or CRO industries
•A minimum of a bachelor's degree is required,
•preferably in a health or science related field.
•A minimum of 5 years of experience in Clinical Research is required. Global experience is a plus.Knowledge of Work: Demonstrates an understanding of regulatory requirements including a working knowledge
•of FDA GCP and ICH guidelines Must have knowledge of EDC systems
•Teamwork: Must be able to present reports and updates at Project and Staff meetings (PowerPoint and Excel)
•Decision Making/Problem Solving: Ability to make independent decisions for CRM back up
•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.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Clinical Research