Clinical Research Assistant 4 REMOTE
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Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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:
* Execute clinical operations deliverables for our clients products
* Lead clinical activities directing and leading the study team as above in alignment with business goals objectives milestones and timelines
* Collaborate with Clinical Affairs management Clinical Program Management Clinical Science Clinical Supply/Logistics Compliance and the various functional groups (R&D BiometricsMedical Affairs) as well as external contacts (study investigators and research coordinators)
* Identify risks that may impact the overall project plan and initiate contingency plans as appropriate
* Develop/Revise and/or provide input in the development of clinical trial related documents including but not limited to:
* Study protocols training materials case report forms informed consents IRB submissions source documents timelines clinical monitoring plans reference manuals supply listings monitoring tools presentations meeting materials (agenda and minutes)
* Lead functional strategy discussions study meetings and alignment meetings as needed
* Function as a Subject Matter Expert where appropriate
* Work independently to manage all clinical tasks and deliverables with limited oversight
* Create and implement training programs and process improvements
* Assists management with departmental audits of clinical studies and procedures
* 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:
* Execute clinical operations deliverables for our clients products
* Lead clinical activities directing and leading the study team as above in alignment with business goals objectives milestones and timelines
* Collaborate with Clinical Affairs management Clinical Program Management Clinical Science Clinical Supply/Logistics Compliance and the various functional groups (R&D BiometricsMedical Affairs) as well as external contacts (study investigators and research coordinators)
* Identify risks that may impact the overall project plan and initiate contingency plans as appropriate
* Develop/Revise and/or provide input in the development of clinical trial related documents including but not limited to:
* Study protocols training materials case report forms informed consents IRB submissions source documents timelines clinical monitoring plans reference manuals supply listings monitoring tools presentations meeting materials (agenda and minutes)
* Lead functional strategy discussions study meetings and alignment meetings as needed
* Function as a Subject Matter Expert where appropriate
* Work independently to manage all clinical tasks and deliverables with limited oversight
* Create and implement training programs and process improvements
* Assists management with departmental audits of clinical studies and procedures
Required Knowledge/Skills/Abilities:
* Extensive experience in all aspects of clinical trial design and execution
* Extensive experience in all aspects of clinical trial design and execution
o Minimum of 8-12 years related experience in a medical device pharmaceutical IVD and/or CRO
o Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
* Thorough understanding of the processes associated with study preparation study management knowledge of Good Clinical Practices (GCPs) monitoring clinical and regulatory operations
* Technical expert in the various aspects of the clinical evaluation process
* History of significant contribution to the success of planning and executing clinical strategies in support of product clearance
* Strong interpersonal and communication skills
* Excellent organizational skills and attention to detail
* Ability to manage multiple priorities
Preferred Qualifications:
* Diabetes experience desirable but not mandatory
* Experience in the medical device industry Pharma BioTech and/or CRO
* Experience in continuous glucose monitoring (CGM) is a plus
* Professional certification (e.g. CCRA (ACRP) CCRP (SoCRA) PMP ACRP RAPS)
Travel Required:
* The job may require travelling up to 25%-30% of the time as needed; some international travel may be required
* Candidate Location: Remotely within United States or local to San Diego California
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
* Bachelors Masters or PhD degree in a technical / scientific discipline and a minimum of 8-12 years related experience in a medical device pharmaceutical IVD and/or CRO
* Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
o Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
* Thorough understanding of the processes associated with study preparation study management knowledge of Good Clinical Practices (GCPs) monitoring clinical and regulatory operations
* Technical expert in the various aspects of the clinical evaluation process
* History of significant contribution to the success of planning and executing clinical strategies in support of product clearance
* Strong interpersonal and communication skills
* Excellent organizational skills and attention to detail
* Ability to manage multiple priorities
Preferred Qualifications:
* Diabetes experience desirable but not mandatory
* Experience in the medical device industry Pharma BioTech and/or CRO
* Experience in continuous glucose monitoring (CGM) is a plus
* Professional certification (e.g. CCRA (ACRP) CCRP (SoCRA) PMP ACRP RAPS)
Travel Required:
* The job may require travelling up to 25%-30% of the time as needed; some international travel may be required
* Candidate Location: Remotely within United States or local to San Diego California
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
* Bachelors Masters or PhD degree in a technical / scientific discipline and a minimum of 8-12 years related experience in a medical device pharmaceutical IVD and/or CRO
* Minimum of 5 - 8 years of leading clinical study preparation and monitoring and leading study team
Key Skills
- CSS
- Cloud Computing
- Health Education
- Actuary
- Building Electrician
About Company
Raland Compliance Partners provides regulatory and compliance solutions in the pharmaceutical, biotech, and medical devices industries.
