Kapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and faster access to results. We are looking for a highly-motivated Clinical Research Associate II - Study Start-Up and Maintenance to help us continue to grow our business and deliver new, life-changing therapies for the cancer patients who need them.
As a Clinical Research Associate II - Study Start-Up and Maintenance, you will:
* Perform study startup and regulatory document maintenance activities for Phase I-IV clinical research projects.
* Assess the progress of clinical projects at assigned sites and ensure clinical projects are conducted, recorded and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements.
* Serve as the primary liaison between site and project team throughout the study lifecycle, from site identification through close-out related to site start-up support and regulatory document maintenance. Respond to site concerns and questions as applicable.
* Document activities via communication logs and other required project documents as per SOPs and project plans. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items for resolution.
* Manage, coordinate and perform Central IRB submissions for North America and local CTIS submissions for Europe, including but not limited to: initial submissions, amendment submission, changes of PIs, safety submission, annual reviews etc..
* Assist the project team with the creation and finalization of the Clinical Site Activation Plan.
* Routinely mentor junior level team members.
Knowledge, skills and abilities:
* Demonstrated knowledge of the clinical research and development process in pharmaceutical and/or biotechnology industries.
* Demonstrated ability to lead and coordinate study start-up and regulatory activities for large-scale clinical trials.
* Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
Requirements:
* Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
* Minimum of 3 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses, including at least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies.
* 5+ years of experience in a study start-up position.
Candidates who also bring in experience in compiling EU CTR submissions via CTIS in Ireland or even other EU CTR countries and with additional language skills are preferred. This position is homebased!