Clinical Research Associate (In-House)

MBX Biosciences•Burlington, MA

About The Position

The Senior Clinical Research Associate (CRA) – In-House is a valuable member of our Clinical Operations Department. This individual acts as MBX’s clinical site facing ambassador, building impactful and sustainable relationships, supporting the clinical sites in proper delivery, and removing executional barriers. This position will be a key enabler of clinical sites’ success in respect to study enrollment, site relationships, data integrity and overall quality. Responsibilities will include a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety reporting. The In-house Sr. CRA may be assigned to 1-2 projects, with flexibility to assume additional project assignment(s). This position is an excellent opportunity for career development as MBX builds out the infrastructure to support our clinical pipeline.

Requirements

Bachelor’s degree with 5+ years related experience.
4+ years of direct experience with clinical site management, CRO/Vendor management, and logistical execution of clinical trials.
Strong understanding of clinical trials, drug development, Phase I through Phase III
Excellent organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Computer skills including proficiency in use of Microsoft Outlook, Word, Excel, and PowerPoint
Strong working knowledge of ICH GCP as relates to clinical trial management.
Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.

Nice To Haves

Experience working in a small company in the biotech or pharmaceutical industry is preferred.
Prior team management experience (direct or indirect)
Experience with Smartsheet and Veeva Vault eTMF systems.

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 all operational responsibilities in compliance with applicable Standard Operating Procedures (SOPs), FDA regulations, and ICH-GCP guidelines.
Involved in the independent completion of activities across multiple clinical studies, ensuring that the safety of the subjects and integrity and validity of the study data are maintained as needed.
Ensures all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials in collaboration with the CTM.
Conducts and oversees all phases of study monitoring (PSV, SIV, IMV, and COV), either independently or jointly with CRO partner.
Oversees subject recruitment and treatment status remotely through IxRS and EDC systems and direct communication with sites to update detailed tracking sheets daily.
Oversees various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.) and follows up to collect outstanding documents.
Maintains current understanding of assigned clinical trial protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned trials.
Contributes to the study budget process by managing and reconciling invoices for 3rd party CROs, Vendors, Consultants and Clinical Sites.
Partners with the CTM for overall project management of trials including preparing meeting agenda, minutes, and action items.
Identifies new approaches to resolve problems and mitigate risks,].
Serves as mentor for junior CRAs and CTAs and those new to the company and/or clinical trial management.
Adheres to all department and company-wide policies regarding conduct, performance, and procedures.
Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising, and managing job performance, delivering feedback, coaching, and providing career development planning and opportunities.
Performs other duties as required.