Sr. Study Start - Up Associate/ Study Start - Up Associate - Novella Clinical
Novella Clinical is looking for experienced Study Start Up professionals to work in our RTP office!
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained in ISSC are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by Novella and its clients.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- As required provides updates during weekly client teleconferences and internal team meetings.
- As required, interacts with sponsors, clinical and contracts teams to discuss sites to be focused on for activation
- Participates in the development of the study qualification questionnaires and review protocols, drawing on medical knowledge and regulatory expertise, to interview sites for potential involvement in studies or trials
- Creates and assists in the dissemination of Confidential Disclosure Agreements (CDAs)/ Questionnaires to sites and follows up accordingly to ascertain interest and to meet study timelines
- Participates in the review and negotiation of the CDAs according to and country specific requirements
- May review and negotiate Informed Consent Forms and follows up with sites and sponsors accordingly
- Assists sites with local IRB/ethics committee submissions
- Contacts sites directly, or through local CRA, as required to resolve issues before IRB/ethics committee submission and final review
- Notifies Regulatory Affairs department when initial essential documents are available for review. Works with Regulatory Department to resolve any concerns
- Assists with the creation of templates for regulatory documents specific to local and central Institutional Review Board (IRB) /ethics committee submission requirements. Assists with assembly and distribution of regulatory documents to sites either directly or through local CRAs in specific countries
- Manages quality and regulatory compliance documentation among investigational sites
- Adheres to study timelines, documents study challenges and communicates updates to Project Manager and ISSC Management
- Manages periodic investigator site file audits maintained at Novella throughout a project to ensure compliance with GCP and Novella’s standard operating procedures. Communicates directly with the site, or with local CRAs in various countries, to achieve stated objectives and to ensure files are maintained in an audit ready condition in at all times.
- Enters Investigator names in the Clinical Trial Management System (CTMS) database.
- Updates CTMS with document collection and all communication made with site during start-up phase.
- Collects and reviews regulatory documents for completeness and accuracy. Responsible for updating CTMS system with receipt of completed documents, scanning to the shared (G) drive, record according to file tracking process and submitting to the file room to be filed throughout the study. Updates tracking forms as required.
- Distributes reportable expedited safety reports and cross reports to sites as needed. Also responsible for tracking and filing of this activity.
- Submit ongoing regulatory documents to clients as needed.
- Accountable for maintaining project activities within scope and budget.
- Assures that the appropriate Novella and/or sponsor SOPs are followed.
- Ensures all project documentation is appropriately filed per Novella SOPs.
- Assists with identification of out of scope activities to ISSC Management and assures that such activities do not begin until the client provides authorization.
- Assists with mentoring of junior staff.
- Performs other duties as required
KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge of clinical research process and medical terminology
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
- Excellent organizational and interpersonal skills
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
- Ability to manage multiple competing priorities within various clinical trials
- Working knowledge of current ICH GCP guidelines and applicable regulations
- Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor entry level ISSC staff
MINIMUM RECRUITMENT STANDARDS:
- BS/BA/BSc, or equivalent, with a minimum of 3 years direct clinical research experience.
- Excellent verbal and written communication skills required.
- Ability to work independently, prioritize and work with a matrix team environment is essential
- Working knowledge of Word, Excel is required
EEO Minorities/Females/Protected Veterans/Disabled
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