Thoracic Oncology Clinical Research Coordinator (Hybrid)

ACTalent

Palo Alto (CA)

Hybrid

USD 41,000 - 43,000

Full time

5 days ago
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Benefits offered by this job

Medical, dental & vision insurance
401(k) retirement plan
Paid time off

Job summary

Actalent is seeking a Clinical Research Coordinator (Thoracic) in Palo Alto to coordinate oncology studies from startup through closeout under PI/senior coordination. You will ensure compliance, safety, and high-quality data while serving as a primary contact for participants, sponsors, and regulators.

The role emphasizes coordinating thoracic oncology trials, managing regulatory submissions (IRB), study documentation, and collaboration with investigators.

Qualifications

  • Two-year college degree and two years of related clinical research or healthcare experience.
  • Hands-on experience as an onsite clinical research coordinator, including coordination of treatment trials.
  • Demonstrated experience in oncology clinical research, preferably thoracic oncology.
  • Proficiency in chart review and extraction of relevant clinical information from medical records.
  • Clinical research assistant and data entry experience, with strong attention to detail and accuracy.
  • Experience working with electronic medical records, with EPIC strongly preferred.
  • Ability to manage clinical research databases, complete case report forms, and maintain study documentation.
  • Familiarity with regulatory processes, including IRB submissions, renewals, and audit participation.
  • Ability to coordinate study logistics, including scheduling, specimen collection, and study visit preparation.
  • Strong organizational and time management skills to handle multiple studies and tasks simultaneously.
  • Effective communication skills to interact with participants, investigators, sponsors, and regulatory personnel.
  • Commitment to patient safety and adherence to ethical standards and study protocols.

Responsibilities

  • Serve as the primary point of contact for participants, sponsors, and regulatory agencies.
  • Coordinate moderately complex clinical studies from initiation through closeout.
  • Determine participant eligibility and facilitate informed consent.
  • Assist in recruitment strategies to enroll suitable participants.
  • Coordinate collection and processing of study specimens with proper handling.
  • Enter and manage patient and lab data for clinical research projects.
  • Manage study databases, flow sheets, logs, and case report forms.
  • Review CRFs for completeness against source documents and correct discrepancies.
  • Ensure compliance with protocols and regulatory requirements.
  • Prepare and submit IRB applications and renewals on schedule.
  • Assemble study kits and monitor scheduling of procedures.
  • Coordinate and maintain study documentation and monitor meetings with sponsors.
  • Monitor study expenditures and collaborate with finance on billing issues.
  • Interact with principal investigator to report progress and ensure safety.
  • Attend monitoring visits and regulatory audits, supporting preparatory work and corrective actions.

Skills

Onsite CRC experience
Oncology clinical research
Data entry accuracy
EPIC electronic medical records
Regulatory coordination
Communication with stake holders
Study coordination
Budget and billing awareness
Monitor visits and audits
Team collaboration

Education

Two-year college degree
Clinical research experience (2 yrs)

Tools

EPIC

Job description

Actalent is seeking a Clinical Research Coordinator (Thoracic) in Palo Alto to coordinate oncology studies from startup through closeout under PI/senior coordination. You will ensure compliance, safety, and high-quality data while serving as a primary contact for participants, sponsors, and regulators.

The role emphasizes coordinating thoracic oncology trials, managing regulatory submissions (IRB), study documentation, and collaboration with investigators.

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