Clinical Research Coordinator 2

Job Description

Job Description

Job Title: Clinical Research Coordinator 2

Job Description

This role leads and coordinates clinical research activities with a focus on oncology and bone marrow transplant studies. The Clinical Research Coordinator 2 works independently on progressively more complex projects, managing significant and key aspects of large studies or all aspects of one or more smaller clinical trials. The position emphasizes treatment-based clinical trials rather than observational studies and requires strong data management, regulatory compliance, and stakeholder collaboration skills.

Responsibilities

• Independently manage major components of large clinical research studies or all aspects of one or more smaller treatment-based clinical trials, particularly in oncology and bone marrow transplant.
• Oversee subject recruitment and enrollment activities to meet study targets, and determine effective strategies for promoting and recruiting research participants.
• Develop and implement plans to retain participants in long-term clinical trials and monitor adherence to study protocols.
• Conduct detailed chart reviews and perform accurate data entry, leveraging electronic medical record systems, with EPIC preferred.
• Oversee data management for assigned research projects, including developing and managing systems to organize, collect, report, and monitor study data.
• Extract, analyze, and interpret clinical and research data to support study objectives, reporting requirements, and decision-making.
• Develop project schedules, targets, measurements, and accountabilities, ensuring that timelines and milestones are clearly defined and monitored.
• Lead regular team meetings, set agendas, guide discussions, and prepare or approve meeting minutes to document decisions and action items.
• Formally supervise, train, and/or mentor new staff or students, including providing instruction on project work and research procedures.
• Participate in or support hiring processes and contribute to performance evaluations for assigned staff, as requested.
• Audit clinical and laboratory operations and procedures to ensure compliance with applicable regulations, protocols, and institutional policies.
• Identify non-compliance or process gaps and provide leadership in recommending and implementing corrective actions and process improvements.
• Monitor Institutional Review Board (IRB) submissions and approvals, and respond promptly to IRB requests, questions, and required modifications.
• Collaborate closely with principal investigators and study sponsors to ensure accurate communication regarding study progress and requirements.
• Monitor and report serious adverse events in accordance with regulatory and sponsor requirements, and resolve study queries in a timely manner.
• Provide leadership in determining, recommending, and implementing improvements to research policies and processes, and help define best practices for the team.
• Develop study budgets in collaboration with staff and principal investigators, distinguishing standard-of-care procedures from research-related procedures.
• Track patient and study-specific milestones and ensure accurate invoicing of sponsors according to the study contract and budget.
• Ensure ongoing regulatory compliance by regularly inspecting study documents and maintaining accurate, up-to-date regulatory files.
• Work with the principal investigator to ensure Investigational New Drug (IND) applications are submitted to the FDA when applicable and that all associated documentation is complete.
• Ensure timely completion and submission of Institutional Review Board renewals and other continuing review documents to maintain study approval.

Essential Skills

• Proven experience as a Clinical Research Coordinator, with the ability to work independently on complex clinical research projects.
• Experience in oncology clinical research or bone marrow transplant clinical trials, or substantial experience with treatment-based clinical trials.
• For candidates with oncology experience: at least 2.5 years of experience as a Clinical Research Coordinator 2 or equivalent level.
• For candidates without oncology experience: at least 5 years of experience managing treatment-based clinical trials (not observational studies).
• Demonstrated experience with chart review and accurate clinical data abstraction.
• Clinical research data entry experience with strong attention to detail and data quality.
• Experience working with electronic medical record systems; EPIC experience strongly preferred.
• Strong knowledge of clinical trial operations, including subject recruitment, consent, enrollment, and follow-up.
• Solid understanding of regulatory requirements, including Institutional Review Board processes and FDA-related documentation for clinical trials.
• Ability to develop and manage data collection and reporting systems for clinical research projects.
• Strong analytical skills to extract, analyze, and interpret clinical and research data.
• Proven ability to lead meetings, coordinate cross-functional activities, and maintain clear documentation.
• Experience supervising, training, or mentoring junior staff or students in a research setting.
• Ability to audit operations and implement corrective actions to maintain compliance and quality standards.

Additional Skills & Qualifications

• Experience working on bone marrow transplant clinical research teams or similar complex oncology programs.
• Experience in treatment-based interventional trials rather than observational studies.
• Experience developing study budgets and differentiating standard-of-care procedures from research-specific procedures.
• Familiarity with tracking patient and study milestones and managing sponsor invoicing according to contractual terms.
• Experience collaborating with principal investigators and external study sponsors on multi-stakeholder clinical trials.
• Familiarity with monitoring and reporting serious adverse events and resolving sponsor or monitor queries.
• Experience defining and implementing best practices, policies, and process improvements within a research team.
• Comfort leading or contributing to hiring processes and performance evaluations for research staff.
• Strong organizational, time management, and communication skills to handle multiple studies and deadlines concurrently.

Work Environment

This position operates in a hybrid work environment, with an expectation of being onsite approximately 34 days per week. The role involves close collaboration with a multidisciplinary clinical and research team, including principal investigators, coordinators, and sponsors. Work is performed across both office and clinical settings, with frequent use of electronic medical record systems such as EPIC and other clinical research data management tools. The environment emphasizes regulatory compliance, high-quality data collection, and continuous process improvement to support complex oncology and bone marrow transplant treatment trials.

This is a Contract to Hire position based out of Palo Alto, CA.

The pay range for this position is $37.00 - $45.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract to Hire position based out of Palo Alto, CA.

This position is anticipated to close on Oct 24, 2026.

This is a fully onsite position in Palo Alto,CA.

About Actalent

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The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.