project manager.

We are seeking a proactive, detail-oriented clinical research leader with proven project management expertise in IITs, a grasp of clinical trial regulations, and exceptional cross-functional communication skills. Key Responsibilities: • Lead end-to-end project management and timeline oversight for assigned investigator-initiated trials (IITs). • Serve as the primary point of contact for investigators, regulatory coordinators, data managers, and study monitors. • Facilitate the timely development, review, and accuracy of clinical protocols, amendments, and study documentation. • Coordinate regulatory submissions and filings, including FDA IND, DSMB, and IRB requirements. • Oversee study data quality, review monitoring findings, and maintain audit-ready regulatory files. • Manage competing operational priorities across active studies while upholding patient care and protocol integrity. Required Qualifications & Skills: • Proven clinical research project management experience, preferably with Investigator-Initiated Trials (IITs). • Comprehensive knowledge of clinical trial protocols, study documentation, and GCP regulations. • Direct experience with FDA IND, DSMB, and IRB submission processes. • data review skills and ability to address and resolve monitoring findings. • Exceptional organizational, prioritization, and multidisciplinary communication skills.

salary: $59.99 - $60 per hour
shift: First
work hours: 8 AM - 5 PM
education: No Degree Required

Responsibilities

• Lead end-to-end project management and timeline oversight for assigned investigator-initiated trials (IITs).
• Serve as the primary point of contact for investigators, regulatory coordinators, data managers, and study monitors.
• Facilitate the timely development, review, and accuracy of clinical protocols, amendments, and study documentation.
• Coordinate regulatory submissions and filings, including FDA IND, DSMB, and IRB requirements.
• Oversee study data quality, review monitoring findings, and maintain audit-ready regulatory files.
• Manage competing operational priorities across active studies while upholding patient care and protocol integrity.




Skills

clinical research

clinical trial protocols

communication skills

Qualifications

Years of experience: 0 years

Experience level: Experienced

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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.