Job Title: Sr. Clinical Trials Associate/Clinical Research Associate I
Work Schedule: Full-time
Job Classification: Exempt
This job reports to: Sr. Director of Clinical Operations and Research
The Sr. CTA/CRA will help with execution and maintenance of clinical studies according to ICH and GCP standards. Works with the clinical team for designated project communications, correspondence, and associated documentation. Maintains, updates, and may establish various databases for clinical activity tracking. Assists team in tracking incoming and outgoing clinical and regulatory documents and updates for investigator sites and maintains the eTMF. Manage the Imaging platforms and tracking of all study related imaging.
This is an opportunity for an experienced Sr. CTA / CRA position to have the opportunity to function at a higher level with mentorship in a fast-paced start-up environment. The ideal candidate will be involved with developing and creating best practices and process development.
- Major Responsibilities and Essential Duties:
- Develop a strong understanding of clinical study protocols.
- Prepares, handles, distributes, files and archives clinical documentation and reports.
- Independently maintains the internal Trial Master File (eTMF) in accordance with the DIA’s reference model and periodically reviews (QC’s) to ensure accuracy and completeness.
- Independently and proactively maintains and updates the CTMS (Clinical Trial Management System) with site information, study contacts, regulatory documents, CRA IMV visits, tracking of IMV reports and runs reports as requested.
- Independently and proactively manage the imaging platforms to ensure all imaging (CTs, angiograms, etc.) required for the trial is uploaded and filed in the appropriate folders.
- Accurately updates and maintains clinical systems within project timelines.
- In collaboration with the Sr. Director of Clinical Research, responsible for tracking, filing and follow up of SAEs with clinical sites in a timely manner, per the Safety Management Plan.
- Responsible for taking and issuing meeting agendas and minutes for designated clinical team meetings.
- Review and track site payments and vendor invoices in a timely and quality manner with the Sr. Director of Clinical Research.
- Helps prepare for CRA, Study Coordinator or Investigator Meetings, as needed, including scheduling, tracking, preparation and creating, distributing, and filing of meeting minutes.
- Maintains tracking information for study activities, including site activation, SIV, IMV and COV preparation and training documents for newly onboarded team members.
- Preparation of Regulatory Binders for Clinical Sites.
- Schedules meetings with internal and external teams, as needed.
- Partners with other functional areas and clinical sites to track clinical samples for the PK study.
- May need to at times do a clinical data review or an informed consent development and review.
- Work with the Clinical Trial Managers on monitoring of data including query resolution, as needed.
- May be asked to support team members with clinical trial execution. Completes assigned responsibilities in a quality and timely manner.
- Will work across multiple studies.
- Other clinical and/or regulatory assignments as needed and requested by the Associate Director of Clinical Research.
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with the company’s Standard Operating Procedures.
- Minimum Requirements:
- Bachelor’s degree preferably in the areas such as biological science, health care management, life sciences or nursing
- Minimum of 2 to 4 years of related experience and/or combination of experience/education/training
- Understanding of the eTMF structure and regulatory document requirements for site activation is required
- Understanding of the drug development process, GCP and ICH standards
- Experience with CTMS
- Experience with Imaging and EDC platforms
- Experience with Microsoft Word, Excel, PowerPoint and Outlook
- Excellent written and oral communication skills and ability to develop relationships with internal and external personnel in area of expertise
- Excellent computer literacy skills, including proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Strong attention to detail, organized, quick learner, and self-motivated
- Efficiently prioritize multiple tasks and utilize time management
- Able to manage large databases and maintaining paper and electronic documents
- Ability to work independently and as a member of a team and to communicate frequently with team members on risks and escalate issues as appropriate in a timely manner.
- Ability to work well under pressure and time constraints for competing priorities
- Smart, efficient, and even- tempered
- Valid CA Driver’s License, clean DMV record, and proof of auto insurance
Essential Mental/Physical Functions:
- Sit for extended periods of time using a computer or phones
- Share a workspace and maintain good order
- Lift up to 20 lbs. infrequently
- Work alone or with others in an office environment
- PC proficiency
- Microsoft Office (Word, Excel, and PowerPoint)
- Office Equipment (scanner, copier, phones)
Additional Comments: May require up to 10% travel
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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