Clinical Research Assistant 3-USD
Spectraforce
San Diego, California
Remote
2 hours ago
Job Description
Job Title: Clinical Research Assistant 3
Duration: 12 Months
Location: San Diego, CA (Remote)
Travel Required:
• The job may require travelling up to 5%-15% of the time as needed; some international travel may be required
• Candidate Location: Remotely within United States or local to San Diego, California
Position Summary:
• The Clinical Trial Lead (CTL) / Study Lead will establish, track and deliver clinical operations milestones
• The CTL / Study Lead will provide direction and leadership to the clinical operations study team and manage daily clinical operations management and execution
• CTL / Study Lead is the single point of accountability for all stages of clinical operations activities, from early study design, start-up, active study, and close-out
• Candidates will have extensive prior experience in similar role with proven track records of successful clinical study completion with adherence to timelines, budget, and milestones
• Candidates will have in-depth knowledge of applicable clinical research guidelines and regulations, as well as software, tools, and systems used in clinical conduct (e.g., CTMS, eCRF, TMF, etc.)
Essential Duties and Responsibilities:
• Lead cross-functional trial teams (Site Management, Monitoring, Data Management, Biostats, Safety, Clinical Logistics).
• Ensure protocol adherence, timely data entry, query resolution, and deviation management.
• Maintain inspection-ready documentation, drive continuous improvement and lessons learned.
• Serve as the central point of contact for internal/external stakeholders
• Prepare updates, risk summaries, and decision briefs to senior leadership
• Develop timeline plans and proactively manage path to meet trial milestones (e.g. FPI).
• Provide robust vendor oversight (e.g. CROs), escalate and remediate as needed.
• Develop Clinical Investigation Plan, Informed Consents, and training materials.
• Prepare and oversee Central IRB submission.
• Review Clinical Monitoring Plan, Data Management Plan, Case Report Forms, etc.
• Work independently to manage all clinical tasks and deliverables with limited oversight
Required Knowledge/Skills/Abilities:
• Minimum of 5 years of study management (All phases - planning, execution and close out study phase experience)
• Thorough understanding of the processes associated with study preparation, study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations
• Minimum of 3 years working on Medical Device Regulated Studies (Feasibility, pivotal and/or post market approval study designs)
• Detailed oriented, strategic thinking, problem solver, and drive decision making.
• Excellent communication both verbal and written
• Ability to manage multiple priorities.
• Prior inspection/audit participation
• Familiar with post market clinical follow-up, registries, real-world evidence, or adaptive designs.
Preferred Qualifications:
• Diabetes experience
• Experience in continuous glucose monitoring (CGM)
• Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS)
Functional/Business Knowledge
• Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
Scope
• Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Judgement
• Exercises good judgment in selecting methods and techniques for obtaining solutions.
• Normally receives little instruction on day-to-day work, general instructions on new assignments.
Experience and Education
• Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or
• Master’s degree and 2-5 years equivalent industry experience, or
• a PhD and 0-2 years’ experience.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.
Duration: 12 Months
Location: San Diego, CA (Remote)
Travel Required:
• The job may require travelling up to 5%-15% of the time as needed; some international travel may be required
• Candidate Location: Remotely within United States or local to San Diego, California
Position Summary:
• The Clinical Trial Lead (CTL) / Study Lead will establish, track and deliver clinical operations milestones
• The CTL / Study Lead will provide direction and leadership to the clinical operations study team and manage daily clinical operations management and execution
• CTL / Study Lead is the single point of accountability for all stages of clinical operations activities, from early study design, start-up, active study, and close-out
• Candidates will have extensive prior experience in similar role with proven track records of successful clinical study completion with adherence to timelines, budget, and milestones
• Candidates will have in-depth knowledge of applicable clinical research guidelines and regulations, as well as software, tools, and systems used in clinical conduct (e.g., CTMS, eCRF, TMF, etc.)
Essential Duties and Responsibilities:
• Lead cross-functional trial teams (Site Management, Monitoring, Data Management, Biostats, Safety, Clinical Logistics).
• Ensure protocol adherence, timely data entry, query resolution, and deviation management.
• Maintain inspection-ready documentation, drive continuous improvement and lessons learned.
• Serve as the central point of contact for internal/external stakeholders
• Prepare updates, risk summaries, and decision briefs to senior leadership
• Develop timeline plans and proactively manage path to meet trial milestones (e.g. FPI).
• Provide robust vendor oversight (e.g. CROs), escalate and remediate as needed.
• Develop Clinical Investigation Plan, Informed Consents, and training materials.
• Prepare and oversee Central IRB submission.
• Review Clinical Monitoring Plan, Data Management Plan, Case Report Forms, etc.
• Work independently to manage all clinical tasks and deliverables with limited oversight
Required Knowledge/Skills/Abilities:
• Minimum of 5 years of study management (All phases - planning, execution and close out study phase experience)
• Thorough understanding of the processes associated with study preparation, study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations
• Minimum of 3 years working on Medical Device Regulated Studies (Feasibility, pivotal and/or post market approval study designs)
• Detailed oriented, strategic thinking, problem solver, and drive decision making.
• Excellent communication both verbal and written
• Ability to manage multiple priorities.
• Prior inspection/audit participation
• Familiar with post market clinical follow-up, registries, real-world evidence, or adaptive designs.
Preferred Qualifications:
• Diabetes experience
• Experience in continuous glucose monitoring (CGM)
• Professional certification (e.g., CCRA (ACRP), CCRP (SoCRA), PMP, ACRP, RAPS)
Functional/Business Knowledge
• Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
Scope
• Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Judgement
• Exercises good judgment in selecting methods and techniques for obtaining solutions.
• Normally receives little instruction on day-to-day work, general instructions on new assignments.
Experience and Education
• Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or
• Master’s degree and 2-5 years equivalent industry experience, or
• a PhD and 0-2 years’ experience.
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.