Overview
Sr. In-House CRAThe Senior In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and all applicable regulatory requirements. The Sr. In-House CRA may assist in program level status tracking and reporting across multiple studies. The Sr. In-House CRA may also be referred to as a Clinical Trial Associate on some contracts.
Responsibilities
- Under the high level supervision of the project site management staff oversight lead (i.e., Clinical Trial Manager, Lead CRA, Clinical Project Manager, etc.)
- Possesses working knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.).
- Has solid knowledge of Good Clinical Practices and country regulatory requirements.
- Independently collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements.
- Performs upload of essential documents into the trial master file.
- Independently communicates and coordinates effectively with internal project staff members and site staff.
- Independently completes IRB/EC submissions for sites or submits to central IRB/EC on behalf of the site.
- Provides project teams with trial progress tracking by updating the Clinical Trial Management System and other software tools.
- Provides mentorship and training to junior staff on the project
- Assists in audit preparation activities as needed.
- Assists the CRA in Issue and Action Item (AI) resolution post visit and assists with tracking AIs to completion.
- Tracks site training
- Tracks site recruitment efforts and collect/review site screening logs.
- Assists with the review of the database to assess data currency and may assist site teams with resolving data queries/discrepancies.
- Reviews site specific language in informed consent forms prior to submission to the IRB/EC.
- Assists with preparing and independently conducts training and retraining of site staff.
- Prepares meeting agendas and meeting minutes.
- May assist in preparing study documents.
- May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots.
- May assist experienced CRA in the conduct of remote and/or on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.
- May perform remote review and monitoring of Informed Consent Forms and other source documents.
- May assist with preparation of DSMB meeting materials.
- Performs other duties as assigned
- Complies with all policies and standards
Qualifications
- Bachelor's Degree Scientific discipline preferred, or directly applicable work experience preferred Required
- 1-3 years of relevant clinical research experience, (as a CTA, in-house CRA, study coordinator, etc.) Required
- Proficient with MS Office Suite High
- Excellent computer and organizational skills High
- High attention to detail required High
- Ability to work on varying projects and exercise critical thinking High
- self starter who can work independently and a team player who can work cross functionally with limited oversight High
- Knowledgeable in clinical research operations, including interpretation and implementation of country specific regulations and ICH guidelines, as required High
- Excellent organizational, interpersonal, and communication skills both oral and written High
- Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High
- Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High
- Ability to collaborate with internal and external colleagues and work well in a team oriented setting High
If you're looking for a career where your work
advances global health and where
scientific excellence meets real-world impact, join us and be part of something bigger.
One Team, One Purpose.Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our
Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Work From Home Anywhere in the US
- Casual Dress Code & Work Environment
CONNECT WITH US!Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
