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

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 naive to treatment with Bacillus Calmette-Guerin (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 Research Associate (CRA)/Clinical Trial Manager (CTM) 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 within established timelines.
• Ability to work independently as well as in a team 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 perform 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 New York City 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 perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Salary Requirements are between $115,000 - $125,000 based on experience and qualifications.

Why You'll Love Working at Protara

• Collaborative, open, 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, vision, and life insurance.
• Matching 401(k) Retirement Plan.
• Flexible working hours/schedule.
• Generous Paid 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 practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, creed, religion, national or ethnic origin, citizenship status, age, sex or gender, gender identity or expression (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.