Title: Senior Clinical Trial Associate
Location: Waltham, MA
In this Clinical Operations role, the Senior Clinical Trial Associate (CTA) is responsible for supporting the Clinical Operations team to execute on clinical strategies to deliver successful operational outcomes across one or more clinical trials.
Duties & Responsibilities:
- Supports the Clinical Project Manager and is responsible for coordination and tracking of logistics in support of clinical trials
- Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects, as applicable
- Assist the Clinical Project Manager in site management activities such as the review of monitoring reports, tracking of site visits, etc
- Assist in the planning, execution, and closeout of clinical trials
- Responsible for resolution of specific study requests and issues as applicable
- Liaison to Contract Research Organization (CRO) and review study related documents as needed
- Reviews and contributes to Protocols, Case Report Forms, Informed Consent Forms, etc for a thorough understanding of study drug and procedures
- Participate at Investigator meetings as applicable
- Coordinate and track clinical trial equipment and supplies as applicable
- Review and track vendor invoices against contracts and coordinate approval
- Responsible for oversight and QC of Trial Master File
- Responsible for agendas and meeting minutes for clinical study execution team meetings
- Responsible for set-up and management of ClinicalTrials.gov postings
- Provide administrative support to clinical operations team as needed
Qualifications & Skills:
- Bachelor’s degree in health sciences or related field.
- Minimum of 3 years’ experience in clinical research with at least 1-2 years’ experience as a Clinical Trial Associate or similar position
- Some Clinical Monitoring experience and trainings preferred
- TMF experience required
- Documented training, knowledge and application of current FDA Regulations, ICH-GCP guidelines in clinical trials required.
- Ability to handle a high volume of highly complex tasks within a given timeline.
- Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff)
- Excellent interpersonal and negotiation skills
- Strong verbal and written communication and presentation skills
- Proactively seeks out and recommends process improvements
- Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
- Experienced in various Clinical Trial Management Systems and Electronic Trial Master Files management systems
- Past experience working for CRO and/or Sponsor preferred