Clinical Trials Management Associate

Clinical Trials Management Associate
  • $60 per Hour
  • Temporary
  • Foster City CA, US Foster City SAN MATEO US 94404
Job Ref: JO000127009
Sector: Clinical
Sub-sector: Reg & Compliance
Date Added: 29 December 2021

Job Title: Senior Clinical Trials Management Associate

1 yr. Renewable Contract or potential for conversion

Onsite training and excellent benefits.


Location: Foster City, CA (HYBRID Model okay)
*Subject to Vaccine Mandate*
Specific Responsibilities and Skills for Position:
- Must meet all requirements for Clinical Trials Management Associate (CTMA) position and must have demonstrated proficiency in all relevant areas
- Serves as the key biomarker operational contact with internal and external stakeholders, for successful implementation of biomarker strategy in (GS) and Collaborative (CO) programs
- Participate in multiple Phase 1-3 teams to manage biomarker implementation in clinical trials
- Plans and coordinates all operational activities required with the collection, delivery and analysis of biomarker samples within a clinical trial
- Provides sample management expertise to the Study Management Teams (SMTs)
- Accountable for ensuring biomarker samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- Collaborate with biomarker biology to translate sample processing and handling instructions from research setting to the clinical setting
- Primary interface for operational activities between the SMT and biomarker laboratory vendors; Provides the day-to-day operational management of biomarker vendors to ensure
delivery against contracted scope of work
- Able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions
- Participate in or manage project meetings and conference calls with CROs, vendors, and multi-functional teams
- Able to anticipate obstacles and proactively develop solutions to achieve project goals
- Develop a general understanding of functional issues and routine project goals from an organizational perspective
- Participate oral presentations as applicable
- Interact and cooperate with individuals in other functional areas to address routine study issues
- Develop tools and processes that increase measured efficiencies of the project
- Assist in trainings for Clinical Trials Management Associates (CTMAs) and Clinical Project Assistants (CPAs),
- Assist in selecting Contract Research Organizations (CROs) or vendors as needed
- Assist with the setting and updating of study timelines
- Participate in departmental, or interdepartmental, strategic initiatives under general supervision
- Conduct vendor visits and provide site training, as needed under general oversight
- Ensure that the site complies with the protocol and regulatory requirements for GS studies
- Review of protocols, informed consents, and relevant study documents
- Travel may be required
- Excellent verbal, written, interpersonal and presentation skills are required
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint and Excel
Experience and Skills:
- At least 4+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline
- At least 2+ years of experience and a Masters' degree or higher; scientific discipline preferred
-Pharmaceutical industry experience or experience working as a clinical trial
coordinator within a clinical trial setting is a plus
-Clinical or biological laboratory experience with evidence of involvement in the
processing and/or analysis of biological samples is a plus

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.


28/01/2022 12:00:00
USD 60.00 60.00 Hour
Contact Consultant:
Sam Royall

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