Clinical Study Assistant

ICON Strategic Solutions; San Francisco (CA); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Competitive base salary

Health, dental, vision

Retirement plans

Life insurance

Employee assistance programs

Wellbeing resources

Job summary

ICON is seeking a Clinical Trial Assistant in a hybrid role based in San Francisco, CA. The CTA supports trial delivery from protocol through closeout, coordinating eTMF/CTMS setup, comms, access control, and regulatory compliance.

The position requires 1+ year in clinical trials, strong organizational and communication skills, and proficiency with MS Office; Oncology experience is a plus. On-site 3–4 days a week with some home days.

Qualifications

• High school diploma or GED with four years relevant experience; Bachelor's degree or health-professional certification preferred.
• At least 1 year experience as a CTA, CRC, or related role in clinical trials.
• Oncology experience is a plus; strong organizational and presentation skills.
• Ability to manage multiple tasks with meticulous attention to detail.
• Excellent written and verbal communication; proficient in MS Word/Excel/PowerPoint/Outlook.

Responsibilities

• Support the study team to ensure timely, within-budget, high-quality delivery from protocol through study closeout.
• Lead setup of eTMF and CTMS systems and ensure information is updated per ICH/GCP and SOPs.
• Create and maintain communication platforms for the study team.
• Control systems access for studies and related platforms.
• Assist with regulatory submissions and TMF quality checks.
• Facilitate financial activities including IO/PO setup and invoice processing.
• Support monitoring visits, MVR tracking, and data reconciliation as needed.
• Coordinate and arrange internal and external meetings and take minutes.

Skills

Organization

Presentation skills

Multitasking

Team player

Communication skills

MS Office

Education

High School Diploma / GED

Bachelor's degree preferred

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Clinical Trial Assistant - Hybrid in San Francisco, CA

ICON is a global healthcare intelligence and clinical research organization united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organization, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

What you will be doing:

The Clinical Trial Assistant is a member of the clinical trial team supporting delivery of clinical studies within the sponsor. The CTA will support the study team to ensure the operational deliveries are executed then the expected timeline, approved budget, and at high quality from protocol development through study setup, maintenance, close out and study archiving.

• The CTA supports the study team in delegated activities and provides technical, administrative and logistical support to ensure efficient execution of clinical trials in line with ICH/GCP sponsor SOP's and regulatory regulations.
• Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's
• Create and maintain communication platforms (i.e. MS Teams, SPOL, group e-mail list) for the study team
• Control systems access for assigned studies but not limited to IxRS, EDC, CT's, and eTMF
• Support clinical trial registration and disclosure on websites per applicable regulatory requirements
• Responsible for overall TMF status. Guide study team members on the eTMF/paper TMF document transfer and archival. Lead the quality check (QC) per the TMF plan. Help draft TMF plan
• Facilitate finance related activities such as sign off, IO and PO setup, processing invoices, track accruals and budget for maintenance and reconciliation for sites and third-party vendors
• Support oversight of monitoring visit report review. Activities include updating MVR trackers and overseeing MVR review metrics
• May support data oversight and reconciliation efforts vendor systems, SAEs, protocol deviations and more as needed per study
• Coordination and tracking of clinical supplies
• Coordinate and arrange internal and external meetings, including but not to study team meetings, vendor defense meetings, investigator meetings, and committee review meeting take meeting minutes as needed.
• Compile and maintain the clinical trial related lists and logs, including but not limited to study document version tracker, decision risk log, contact list, Q&A log, vendor list, and specific training log.
• Draft and distribute newsletters communications Asia materials to internal and external stakeholders
• Complete delegated tasks during audit and inspection by regulatory authorities

What you need to have:

• High school or GED with four years relevant experience. Bachelor's degree or above (Life Sciences preferred) or certification in a related health profession (i.e. nursing, medical or laboratory technology) from an accredited institution is preferred.
• At least 1 year experience as a CTA, CRC, or other role in clinical trials.
• Oncology experience a huge plus!
• Proven organizational and presentation skills
• Ability to manage multiple tasks with meticulous attention to detail
• Quick learner and team player
• Excellent written and verbal communication skills
• Computer proficiency in Microsoft Word, Excel, PowerPoint and Outlook
• Good knowledge of the ICH/GCP
• Position is on site 3-4 days a week at client office in South San Francisco, CA and days from home.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programs including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programs and wellbeing resources

  Benefits may vary depending on role and location.

  Visit our careers site to read more about the benefits ICON offers.

  Inclusion and Accessibility

  ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

  If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.