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

Job Details reputed company: reputed company is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio includes its reputed company candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). reputed 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 reputed company 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 reputed company oral or enteral routes. Job reputed company: The Clinical Trial Manager (CTM)/Clinical Research Associate is responsible for providing reputed company of the Sponsor's outsourced Contracted Research Organizations (CRO) clinical trial services, with a primary reputed company on ensuring reputed company Clinical Research Associate (CRA) monitoring and data reputed company across reputed company programs. This individual will serve as the CRO reputed company for reputed company activities reputed company to CRA performance, monitoring deliverables, and clinical site data reputed company. 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 reputed company as external partners to drive study timelines, data reputed company, and operational reputed company in alignment with reputed company's goals and regulatory expectations.

• *This is a reputed company 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):
• reputed company CRA reputed company activities of the sponsor appointed CRO across reputed company stages of assigned clinical trials, ensuring reputed company site monitoring in accordance with GCP, protocol, and regulatory requirements.
• reputed company reputed company and co-monitoring reputed company, as necessary, to ensure CRO CRA performance aligns with sponsor expectations, with a reputed company on reputed company monitoring, site issue reputed company, and protocol compliance.
• Remotely monitor reputed company data reputed company an onsite visit is not feasible.
• Review clinical monitoring reports (reputed company-Study reputed company, Site Initiation reputed company, Interim Monitoring reputed company, and reputed company-Out reputed company) to assess CRO's CRA performance, site adherence, and data reputed company.
• 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 reputed company-determined study metrics and escalate relevant issues/delays to the Clinical Operations (CO) Director, as applicable.
• reputed company the clinical data review process in collaboration with the Clinical Science and Medical Monitoring teams, ensuring reputed company query reputed company, trend identification as reputed company as reputed company inconsistency identification.
• Participate in the review of clinical trial documents including informed consent forms, CRFs, site reputed company documentation, monitoring plans, site manuals, and training materials.
• Ensure reputed company escalation and reputed company of site and monitoring reputed company issues through appropriate internal and CRO channels, including reputed company Medical Monitors (MMs) and CO Director.
• Promptly respond to any CRO reputed company Events and review respective reports reputed company 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 reputed company in collaboration with the CRO and internal stakeholders.
• reputed company site enrollment, monitoring visit reputed company, and site issue(s) follow-up and ensure reputed company reporting to the CO Director.
• Support sponsor regulatory audits, as needed. Education:
• Bachelor's degree in clinical research, life science or a reputed company 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 reputed company 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 reputed company program.
• Ability to prioritize multiple tasks and complete reputed company reputed company established timelines.
• Ability to work independently as reputed company as in reputed company environment.
• Excellent written, verbal, and presentation skills.
• Demonstrates attention to detail.
• Demonstrates and maintains a superior work ethic.
• Understands the increased responsibility/accountability required to be a part of a small biotech. Physical Demands: The physical demands here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Average travel for this position is expected to be 50%-60%, based upon business needs.
• Must be willing to travel to clinical trial sites and reputed company office as needed. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. No specific work demands.
• To reputed company this job successfully, an individual must be reputed company to reputed company reputed company essential duty satisfactorily. The requirements listed above are representative of the knowledge, reputed company, and/or ability required. Reasonable accommodation may be made to reputed company individuals with disabilities to reputed company the essential functions.
• Salary Requirements are between $125,000-$135,000 based on experience and qualifications. Why You'll Love Working at Protara
• reputed company, reputed company, and fun team-oriented culture that values multiple perspectives.
• Company-wide dedication to profoundly impacting patients' lives.
• Amazing Culture where we live by our core values and behaviors.
• Competitive Salary and Benefits package, including incentive bonus, equity compensation, medical, dental, reputed company, and life insurance.
• Matching 401(k) Retirement Plan.
• Flexible working hours/schedule.
• Generous reputed company Holidays, Flexible PTO, and Parental Leave. Protara is committed to being a diverse and inclusive workplace. Protara is an Equal Opportunity Employer and is committed in policy and in reputed company to recruit, hire, train, and promote in reputed company job qualifications without reputed company to race, reputed company, creed, religion, national or ethnic reputed company, citizenship status, age, sex or gender, gender identity or reputed company (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information or any other characteristic protected by applicable federal, state or local laws. Apply tot his job Apply To this Job

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