C3 Research Associates is a small, full-service Clinical Research Organization (CRO), established in 2008. As a decentralized organization all of our positions are home-based. We currently have an opening for a Clinical Trial Management Associate (CTMA). This position can be located anywhere in the US.
As part of the Clinical and Data Operations team, the CTMA is responsible for performing tasks that support the Clinical and Data Operations team with the implementation and conduct of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study tracking and reporting. The CTMA implements trial set-up, execution, oversight, tracking and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
- Act as a point of contact for Sponsor Representatives, vendors, and third-party service providers and collaborate on scope of work and project activities to ensure deliverables are completed on time and key performance indicators are monitored. May serve as the key operational contact under supervision.
- Proactively identifies operational challenges in collaboration with team members. Provides and implements solutions.
- Contribute to the design of study manuals, project-specific plans, and other required documents.
- Develops site tools and oversees clinical trial start-up activities.
- Assists in the development and maintenance of the clinical trial master file.
- Assists in ensuring consistency and best practices for all study processes, protocols, and plans.
- Leads the tracking and reporting of study operations activities and metrics including; creates and maintains study tracking tools, project files, overviews of study status.
- Conducts site visits to perform routine data collection, source data verification, and review routine regulatory documents in compliance with the protocol, regulatory requirements, Standard Operating Procedures, and Monitoring Plan, as required.
- Participates in the specification process of the EDC or other clinical systems, as appropriate.
- Review CRFs, data listings, and database to ensure all captured data follows the rules outlined by the protocol and data management plan.
- May review and manage monitoring reports and site action items.
- Generate queries to resolve problematic data identified during every aspect of the data management process.
- Maintains internal Clinical Operations databases and document repositories.
- Performs necessary administrative functions.
- Consistently performs duties within established Standard Operating Procedures, and in accordance with Good Clinical Practice.
- Mentor and provide training as requested for less senior members of Clinical Trial Team.
- Provide suggestions and contribute to implementation of process improvements in support of team, department, and company goals.
- Perform other duties and responsibilities, as assigned.
Behavioral Competencies Required
- Minimum of 4 years of related clinical research experience including at least 2 years of clinical trial experience at a CRO or Sponsor.
- Knowledgeable about CTMS, eTMF, EDC, and IWRS systems
- Working knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operations aspects of clinical studies and the management of TMF content.
- Familiarity with the DIA Trial Master File Reference model and a demonstrated understanding of records management best practices.
- Previous experience in a small or start-up company with a remote work environment is desirable.
- Proficiency with Microsoft Office Suite, electronic data capture systems, and other database programs is required.
- Must have the ability to work independently and maintain confidentiality.
- Excellent oral and written communication skills and the ability to communicate effectively with all levels. This position requires the ability to work with outside clients, vendors, and agencies in a professional manner.
- Attention to detail and accuracy is essential.
- Ability to work independently in a fast-paced environment.
- Strong Communication, interpersonal, and organizational skills.
Must possess excellent interpersonal skills. Must have the ability to build and maintain positive relationships with management, peers, and subordinates. Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail required
Physical Demands Required:
Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs. May encounter prolonged periods of sitting.
To perform this job successfully, an individual must be able to perform each essential duty as outlined in the contract and/or work order satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
C3 Research is very proud to offer our employees a generous benefits package which includes a 401K, healthcare insurance program which offers a variety of health plan options consisting of medical, dental, and vision which covers 100% of the employee insurance premium. We also offer a health savings plan, employee assistance program, staff recognition program, paid holidays, a flexible PTO policy, and so much more.
C3 Research is committed to offer:
- A commitment to support a work-life balance
- A competitive salary and benefits package
- Opportunities for growth and upward career progression
- Opportunity to work on multiple projects and explore cross functional roles
- A fun and collaborative work environment
- Cutting edge technology to support day to day activities
- Top training and professional development