Clinical Research Associate (In-House)
MBX Biosciences, Inc.
4 months ago
On-site
Burlington, MA
Clinical Research and Development
Key Responsibilities:
- Acts as primary liaison for assigned study sites, CROs and Vendors to convey project information, answer questions and resolve issues in accordance with the CTM escalation pathway.
- Develops and reviews regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits.
- Attends, prepares and presents materials for Investigator Meetings and study-specific training for assigned trials when needed.
- Conducts operational responsibilities in compliance with applicable SOPs, FDA regulations, and ICH-GCP guidelines.
- Completes activities across multiple clinical studies, ensuring subject safety and integrity/validity of study data.
- Ensures regulatory documents and study supplies are maintained during the lifecycle of assigned trials in collaboration with the CTM.
- Conducts and oversees study monitoring phases (PSV, SIV, IMV, and COV), independently or jointly with a CRO partner.
- Oversees subject recruitment and treatment status remotely through IxRS and EDC systems; updates detailed tracking sheets daily.
- Oversees tracking sheets for document status (distribution, status, retrieval of protocol, IB, etc.) and follows up to collect outstanding documents.
- Maintains understanding of assigned protocols and trial manuals/plans to meet quality and deliverables.
- Manages and reconciles invoices for 3rd party CROs, vendors, consultants and clinical sites.
- Partners with the CTM on project management (meeting agenda, minutes, action items).
- Serves as mentor for junior CRAs and CTAs and those new to the company/clinical trial management.
- Adheres to department and company-wide policies.
- Provides oversight and direction to direct/indirect reports (recruiting, training, expectations, appraising, feedback/coaching, career development).
- Performs other duties as required.
Education:
- Bachelor’s degree with 5+ years related experience.
Experience:
- 4+ years of direct experience with clinical site management, CRO/Vendor management, and logistical execution of clinical trials.
- Experience working in a small company in biotech or pharmaceutical industry (preferred).
- Prior team management experience (direct or indirect).
- Experience with Smartsheet and Veeva Vault eTMF systems.
- Strong understanding of clinical trials and drug development (Phase I–III).
Additional Skills and Qualifications:
- Excellent organizational skills and attention to detail; ability to handle multiple tasks efficiently.
- Ability to establish and maintain effective working relationships.
- Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
- Strong working knowledge of ICH GCP.
- Ability to manage others through coaching and supervision.
- Acts as primary liaison for assigned study sites, CROs and Vendors to convey project information, answer questions and resolve issues in accordance with the CTM escalation pathway.
- Develops and reviews regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits.
- Attends, prepares and presents materials for Investigator Meetings and study-specific training for assigned trials when needed.
- Conducts operational responsibilities in compliance with applicable SOPs, FDA regulations, and ICH-GCP guidelines.
- Completes activities across multiple clinical studies, ensuring subject safety and integrity/validity of study data.
- Ensures regulatory documents and study supplies are maintained during the lifecycle of assigned trials in collaboration with the CTM.
- Conducts and oversees study monitoring phases (PSV, SIV, IMV, and COV), independently or jointly with a CRO partner.
- Oversees subject recruitment and treatment status remotely through IxRS and EDC systems; updates detailed tracking sheets daily.
- Oversees tracking sheets for document status (distribution, status, retrieval of protocol, IB, etc.) and follows up to collect outstanding documents.
- Maintains understanding of assigned protocols and trial manuals/plans to meet quality and deliverables.
- Manages and reconciles invoices for 3rd party CROs, vendors, consultants and clinical sites.
- Partners with the CTM on project management (meeting agenda, minutes, action items).
- Serves as mentor for junior CRAs and CTAs and those new to the company/clinical trial management.
- Adheres to department and company-wide policies.
- Provides oversight and direction to direct/indirect reports (recruiting, training, expectations, appraising, feedback/coaching, career development).
- Performs other duties as required.
Education:
- Bachelor’s degree with 5+ years related experience.
Experience:
- 4+ years of direct experience with clinical site management, CRO/Vendor management, and logistical execution of clinical trials.
- Experience working in a small company in biotech or pharmaceutical industry (preferred).
- Prior team management experience (direct or indirect).
- Experience with Smartsheet and Veeva Vault eTMF systems.
- Strong understanding of clinical trials and drug development (Phase I–III).
Additional Skills and Qualifications:
- Excellent organizational skills and attention to detail; ability to handle multiple tasks efficiently.
- Ability to establish and maintain effective working relationships.
- Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
- Strong working knowledge of ICH GCP.
- Ability to manage others through coaching and supervision.