Clinical Research Assistant - Nuclear Medicine Service

ATTB - The Big Jobsite; United States; On-site; USD 50,000 - 70,000; Full time

Job summary

A leading research institute in the United States is seeking a Clinical Research Assistant to support clinical trials from inception to closeout. The role involves managing multiple clinical trials, facilitating compliance with regulatory tasks, and collaborating across departments. Candidates should have a Bachelor's degree and strong organizational skills. This position offers opportunities for growth in the clinical research field.

Benefits

Health, dental, and vision insurance

401(k) with a 6% company match

14 paid holidays and generous vacation policy

Professional development training

Qualifications

• 0-2 years of clinical research experience is preferred.
• Experience with human participants and regulatory compliance is a plus.
• Familiarity with GCP, HIPAA, IRB, and FDA regulations is desired.

Responsibilities

• Assist in managing 2-3 clinical trials administratively and clinically.
• Support regulatory and compliance tasks for VA and IRB.
• Create patient recruitment strategies and prepare IRB submission materials.

Skills

Strong organizational skills

Communication skills

Independent working skills

Proficiency in Microsoft Office

Education

Bachelor's degree or equivalent

Job description

Palo Alto Veterans Institute for Research (PAVIR) is seeking a full-time Clinical Research Assistant to work under the guidance of VAPAHCS Principal Investigator (PI) Dr. Minal Vasanawala. The role involves supporting various aspects of the clinical research program in Nuclear Medicine Service, including facilitating clinical trials from inception to closeout.

The Clinical Research Assistant will assist with the implementation of new and ongoing studies and will play a critical role at every stage of clinical studies, offering opportunities for growth in the clinical research field.

BENEFITS

PAVIR offers a comprehensive employee benefits package, including health, dental, and vision insurance, 14 paid holidays, generous vacation and sick leave policies, a 401(k) with a 6% company match and 3% profit sharing, wellness programs, commuter benefits, and professional development training. We also cover life, short-term, and long-term insurance.

MAIN RESPONSIBILITIES

• Assist in managing 2-3 clinical trials administratively and clinically.
• Support regulatory and compliance tasks for VA and IRB to facilitate study start-up.
• Serve as the primary contact for sponsors regarding administrative and regulatory issues.
• Create patient recruitment strategies and prepare IRB submission materials.
• Assist with collection of study documents like protocol signature pages, Form 1572, PI CVs.
• Coordinate sponsor visits and receive sponsor-specific training for study systems.
• Draft and finalize informed consent forms collaboratively with PI and sponsors.
• Set up patient reimbursement processes per protocol and ICF requirements.
• Collaborate with VA departments to meet study protocol requirements.
• Support logistics for study materials receipt and shipment.
• Act as the primary contact for project communications and documentation.
• Recruit, screen, and enroll research subjects, ensuring protocol adherence.
• Document and report adverse events properly.
• Review laboratory results and follow up on abnormal findings.
• Ensure data integrity and patient safety.
• Handle specimen processing, documentation, and shipping.
• Coordinate monitoring visits, complete CRFs, and maintain study files.
• Report protocol violations and assist with IRB and R&D submissions.
• Manage study closeout activities and system preparations for data lock.
• Maintain study records and participate in process improvements.
• Contribute to SOP development and other departmental duties.

QUALIFICATIONS

Required: Bachelor's degree or equivalent; 0-2 years of clinical research experience.

Desired: Experience with human participants, regulatory compliance, oncology trials, clinical trial education, and familiarity with GCP, HIPAA, IRB, FDA regulations, and electronic medical records. Strong organizational, communication, and independent working skills are essential. Proficiency in Microsoft Office is required. Knowledge of VA systems and procedures is a plus.

ABOUT PAVIR

PAVIR supports research at the VA Palo Alto Health Care System, working with talented scientists affiliated with Stanford University. We are committed to diversity and equal opportunity employment. All employees must have an approved VA appointment and pass a background check. For accommodations, contact [e-mail].