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 III - 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 III - Study Start-Up and Maintenance, you will:
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. Able to respond to site concerns and questions as applicable.
Documents activities via communication logs and other required project documents as per SOPs and project plans. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items for resolution.
Assists the project team with the creation and finalization of the Clinical Site Activation Plan.
Collects, compiles and reviews essential document packages for site activation in accordance with ICH-GCP and/or all applicable local and federal regulatory requirements. Ensures essential documents are sent to the assigned Regulatory specialist for submissions to the FDA and/or for submission for EU and other regions for any type of application (i.e., submissions for the EU via CTIS, submissions of Medical Device trials to IRB/EC and Regulatory Agencies submissions).
Performs study regulatory maintenance activities including but not limited to: collection of updated 1572 or equivalent, Informed Consent Form (ICF) updates resulting from amendments and addenda, distribution and IRB/IEC approval of Protocol Amendments etc.
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..
May participate in the identification and selection of investigators and clinical sites and/or may proactively suggest potential sites based on local knowledge of treatment patterns and clinical trial requirement.
Understands project scope, budgets, and timelines for the trial and is expected to provide input and manage site-level activities and communication to meet project deliverables and timelines are met.Identifies and communicates out of scope activities, operational efficiencies, and process improvements to the Project Manager.
May prepare for and attend Investigator Meetings, Sponsor face to face meetings and global clinical monitoring / project team meetings.
As required, collaborates and builds relationships with Sponsor and other affiliates, medical advisors, and local country staff.
Completes all assigned training programs and applies learning to job responsibilities. Maintains working knowledge of ICH-GCP guidelines as well as all applicable country and local regulations.
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.