Senior Clinical Research Associate
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. The company has a noble and important mission: We make healthy possible.
Amneal is one of the fastest growing pharmaceutical companies in the U.S. and makes healthy possible through its diverse product portfolio that includes more than 200 generic product families, 5 marketed specialty products, and a portfolio of biosimilars, one of which has been filed with the FDA, one near-term filing opportunity and one in late-stage development.
Additionally, Amneal has impressive R&D capabilities that have resulted in one of the industry’s largest generics pipelines with 258 products filed or in development, one investigational drug to augment the Specialty business, and three biosimilars in various stages of development. Amneal’s product range spans injectables and steriles, topicals and transdermals, solid and liquid dosage forms and inhalation delivery systems.
Following its May 2018 combination with Impax Laboratories, Amneal is uniting its 6,500 employees worldwide - who are based across the US, India, and European locations – around its Learn, Lead, Succeed culture. This dynamic entrepreneurial culture encourages all employees to contribute, to work together and to balance strategic thinking/risk taking with the need to achieve results.
As integration work continues, the company is centralizing much of its leadership and key functions in the Bridgewater, NJ area, including the majority of the R&D function. This has resulted in the need to hire several key roles to ensure the continued growth of the business and bring the function together, thereby enabling operational efficiency, close collaboration within the team, and the sharing of ideas and values.
From a Specialty Pharma perspective, Amneal has two large Ph III studies underway for the treatment of Parkinson’s Disease and one Ph IV study for pediatric usage of Zomig. However, Amneal is aggressively continuing to pursue growth through its business development initiatives, and it is anticipated the Clinical Product Pipeline will be greatly expanded in the near future.
Senior Clinical Research Associates (CRAs) in Amneal Pharmaceuticals handle the day-to-day operations of the clinical investigative phase of drug development. They work closely with investigator sites and ensure all studies are conducted with utmost compliance, they assess clinical work undertaken, and provide feedback to the Company and Investigator sites.
The CRA will take charge of keeping investigative reports and providing project communications between the various sites.
They are responsible for monitoring the progress and patient enrollment levels, ensuring the supply of clinical trial materials and representing Amneal in a wide array of forums.
• Conduct site qualification, initiation, monitoring and close-out visits as per specified timeframes in accordance with ICH-GCP, organization / sponsor SOPs (as may be applicable), project specific monitoring plan and all applicable local regulatory requirements.
• Coordinate with the investigator sites to procure documents required for local regulatory submission [e.g. CV, IRB/EC approval (as applicable), etc.] as well as site regulatory package documents by appropriate QC of the documents.
• Coordinate with sites and assist in conducting Investigator meetings.
• Act as main line of communication between investigator, project manager, and sponsor. Maintain effective communications with the investigator site by sending visit objectives prior to the visit, ensuring the investigator is informed about the visit outcomes including the issues and the expected actions, provide support to the site for trouble shooting any issues during the visit, and /or through interim telephonic contacts, by ensuring accurate reporting of issues to project manager / line manager /sponsor as applicable.
• Participate and coordinate with Clinical Research Associate (CRA) and investigators in the development/implementation of clinical protocol, administrative, logistical procedures (including documentation).
• Set up, coordinate, and actively participate in internal and/or project specific conference calls/video conferences etc.
Professional Experience / Qualifications
• Post graduate degree in a relevant life science subject.
• Have a minimum of four years field experience as a Medical Monitor and have solid operational knowledge of clinical development. This could have been gained in a Bio/Pharma company or Clinical Research Organization.
• Excellent interpersonal skills to cooperate in a team environment and deliver conclusions to research managers.
• Excellent communication skills, ability to impart scientific information in a succinct fashion, able to write well and demonstrate excellent interpersonal skills with the ability to engage with a wide audience.
• Uphold ethical clinical practices and maintain advanced safety standards. Ensure Amneal’s standard of compliance is upheld and Amneal is professionally represented.
• Ability and willingness to travel to multiple sites, and invest time developing relationships.
• Have scope for personal advancement.
Masters Degree in life sciences, this could be an RN qualification, PhD or PharmD.