Onsite Oncology Clinical Research Coordinator

Actalent; Palo Alto (CA); Hybrid; USD 41,000 - 51,000; Full time

Benefits offered by this job

Medical, dental & vision

Hybrid work arrangement

401(k) retirement plan

Job summary

Actalent, a clinical research services leader, seeks a Clinical Research Coordinator to support interventional drug studies under supervision of a PI. You will manage data collection, regulatory documents, and study logistics, coordinating from start-up to closeout.

The role involves participant contact, consent, data entry, and regulatory compliance, with on-site duties in Palo Alto and a hybrid work setup.

Qualifications

• Two-year college degree and one year of relevant experience in clinical research.
• Minimum of 1 year of experience as a Clinical Research Coordinator (CRC) or similar role.
• Experience with interventional drug studies in a clinical research setting.
• General knowledge of medical terminology sufficient to understand clinical documentation and study protocols.
• Ability to conduct chart reviews and extract relevant clinical information accurately.
• Ability to collect, manage and enter patient and laboratory data for clinical research projects.
• Experience with administering and scoring study questionnaires and tests, and coding data for computer entry.
• Certifications or active progress toward certification(s) required to perform basic patient measurements and tests, such as phlebotomy and EKG, as applicable.
• Ability to coordinate study activities from start-up through closeout under supervision.
• Strong organizational skills with the ability to maintain regulatory documents, consent forms, subject logs, and study correspondence.
• Valid California non-commercial Class C Driver's License, if applicable.
• Ability to frequently stand, walk, twist, bend, stoop, squat, and use fine light/fine grasping in the course of daily work.

Responsibilities

• Perform administrative support duties related to the collection of clinical data and the coordination of clinical studies under the supervision of the principal investigator and/or study coordinator.
• Serve as a primary contact for research participants, sponsors, and regulatory agencies throughout the duration of assigned studies.
• Coordinate clinical studies from start-up through closeout, supporting initiation, ongoing conduct, and completion of all study activities.
• Schedule and call subjects for study appointments, and contact participants with reminders or other study-related requirements.
• Assist with screening, recruiting, and obtaining informed consent from study participants in accordance with study protocols.
• Review medical records and conduct telephone or in-person interviews to gather clinical and demographic data as needed.
• Prepare, distribute, and process study questionnaires, ensuring timely completion and return by participants.
• Administer standard study questionnaires and tests, score test measurements and questionnaires, and code data for computer entry.
• Perform quantitative review of forms, tests, and other measurements for completeness, consistency, and accuracy.
• Extract data from source documents for research studies as directed, and accurately collect data to complete case report forms.
• Collect and manage patient and laboratory data for clinical research projects, maintaining accurate and up-to-date research project databases.
• Develop and maintain study-related documents such as flow sheets, tracking logs, and master subject logs.
• Perform clerical duties in the preparation and maintenance of regulatory documents, including consent forms and other required documentation.
• Maintain all forms and documents in an organized manner, and file all appropriate study correspondence and records.
• Ensure compliance with research protocols, and review and audit case report forms for completeness and accuracy against source documents.
• Prepare regulatory submissions as directed and ensure that Institutional Review Board renewals and related regulatory requirements are completed on time.
• Coordinate the collection of study specimens according to protocol and ensure proper labeling and documentation.
• Prepare, process, and ship specimens and samples accurately under well-defined requirements and timelines.
• Perform basic measurements and tests on patients, such as obtaining vital signs, and performing phlebotomy and EKG after appropriate training and certification.
• Order and maintain study equipment, supplies, and materials, ensuring that study sites are adequately stocked.
• Process study compensation payments and prepare thank-you letters to subjects upon completion of trial activities.
• Assist with post-study activities, including data clean-up, document archiving, and study closeout tasks.
• Assemble study kits, collect signed consent forms from clinic settings, and perform follow-up data entry and document scanning as needed.
• Work on site 34 days per week, collaborating closely with clinical and research staff to support daily study operations.

Skills

Interventional drug studies

Medical terminology

Chart reviews

Data entry and management

Regulatory documentation

Study coordination

Organizational skills

Regulatory submissions support

Education

Two-year college degree

Job description

Actalent, a clinical research services leader, seeks a Clinical Research Coordinator to support interventional drug studies under supervision of a PI. You will manage data collection, regulatory documents, and study logistics, coordinating from start-up to closeout.

The role involves participant contact, consent, data entry, and regulatory compliance, with on-site duties in Palo Alto and a hybrid work setup.