Clinical Trial Manager/Clinical Research Associate / (Hybrid Role) - TEMP To PERM

Job Details Company Overview: Protara Therapeutics is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes. Job Overview: The Clinical Trial Manager (CTM)/Clinical Research Associate is responsible for providing oversight of the Sponsor's outsourced Contracted Research Organizations (CRO) clinical trial services, with a primary focus on ensuring quality Clinical Research Associate (CRA) monitoring and data integrity across all programs. This individual will serve as the CRO liaison for all activities related to CRA performance, monitoring deliverables, and clinical site data quality. They will also assist with the implementation of risk-based monitoring strategies, as applicable, while ensuring protocol compliance and subject safety. They will play a critical role in clinical data review, management/escalation of site-level issues, and ensure inspection-readiness at clinical sites. This position requires strong collaboration with internal cross-functional teams as well as external partners to drive study timelines, data quality, and operational excellence in alignment with the company's goals and regulatory expectations.

• *This is a Temp to Perm role. It is a remote role. Must be centrally located, no more than 30 miles from a major airport. Essential Duties and Responsibilities include the following (Other duties may be assigned):
• Provide CRA oversight activities of the sponsor appointed CRO across all stages of assigned clinical trials, ensuring quality site monitoring in accordance with GCP, protocol, and regulatory requirements.
• Perform oversight and co-monitoring visits, as necessary, to ensure CRO CRA performance aligns with sponsor expectations, with a focus on quality monitoring, site issue resolution, and protocol compliance.
• Remotely monitor EDC data when an onsite visit is not feasible.
• Review clinical monitoring reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits) to assess CRO's CRA performance, site adherence, and data quality.
• Monitor key risk indicators and site-level performance metrics (e.g., query rates, protocol deviations, enrollment timelines) in collaboration with the CRO and internal stakeholders to ensure alignment with pre-determined study metrics and escalate relevant issues/delays to the Clinical Operations (CO) Director, as applicable.
• Oversee the clinical data review process in collaboration with the Clinical Science and Medical Monitoring teams, ensuring timely query resolution, trend identification as well as EDC inconsistency identification.
• Participate in the review of clinical trial documents including informed consent forms, CRFs, site source documentation, monitoring plans, site manuals, and training materials.
• Ensure timely escalation and resolution of site and monitoring related issues through appropriate internal and CRO channels, including internal and external Medical Monitors (MMs) and CO Director.
• Promptly respond to any CRO Quality Events and review respective reports related to site issues and contribute to CRO CAPA development, as required.
• Review and contribute to CO sections of Clinical Study Reports (CSRs) in collaboration with Clinical Science team.
• Ensure sites' Investigator Site Files (ISF) are inspection ready in collaboration with the CRO and internal stakeholders.
• Track site enrollment, monitoring visit progress, and site issue(s) follow-up and ensure proper reporting to the CO Director.
• Support sponsor regulatory audits, as needed. Education:
• Bachelor's degree in clinical research, life science or a related field is required.
• Minimum of 4+ years of relevant site monitoring experience in the pharmaceutical or biotech industry is required. Supervisory Responsibilities: No Qualifications:
• Knowledge of regulatory guidelines including ICH, GCP, and CFR.
• Prior clinical trial monitoring experience.
• Must be proficient in different EDC platforms including raising queries.
• Must be proficient in MS Office Suite. Certificates, Licenses, Registrations:
• ACRP certification preferred. Other Skills and Abilities:
• Willingness to travel to Protara's sites for each program.
• Ability to prioritize multiple tasks and complete projects

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