Clinical Scientist Consultant
Company Name:
BioBridges, LLC
Overview
Our client is a biopharmaceutical company focused on the discovery and development of treatments for orphan and ultra-orphan disorders.
Their Clinical Divide
In order to keep their phase III program on track, need someone to help with study enrollment.
Project Details
This position is responsible for providing the scientific and operational expertise required to conduct clinical trials in accordance with appropriate regulatory requirements. Works as an integrated member of the clinical team to develop, implement, and manage clinical trial(s) from study design through close out. Manages relationships with external partners to ensure that timelines and deliverables are met.
Development of the clinical strategy, trial design and protocol development including:
Participating in the clinical research required for the study design (e.g. evaluating scientific literature, gathering investigator advice regarding current clinical practice(s) for the indication in question, etc.)
Contributing to the development of study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study-related documents as required.
Participating in estimating clinical study timelines using appropriate project management tools.
2. Manages relationships with one or more assigned investigator sites and vendors including facilitating and participating in budget development, contract negotiations and expenditure oversight.
3. Prepares investigator site lists and participates in their review and approval for inclusion in the study. Plans, coordinates and participates in investigator meetings including developing and presenting assigned sections of the meeting agenda/content.
4. Recommends strategies for and oversees the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency.
5. Conducts periodic review of clinical trial data to ensure timely, consistent and accurate data flow.
6. Presents project progress reports at internal team meetings and investigator meetings as required.
7. Working with appropriate team members, collects files and maintains study-related documents.
8. Participates in the submission of regulatory documents. This includes:
assists in the interpretation of clinical study results in preparation for inclusion in Clinical Study Reports (CSRs) and regulatory submissions
compiles and reviews assigned portions of reports for submission to regulatory agencies, Institutional Review Boards (IRBs), and scientific journals.
9. Addresses and resolves questions from sites and trial monitors regarding trial conduct.
Requirements
BS/BA in a related discipline and a minimum of 5 years of US and/or international experience in clinical research working for a pharmaceutical company or a contract research organization.
Comprehensive understanding of the drug developmental process.
Thorough knowledge of clinical trial design and operations.
Comprehensive knowledge of GCP and ICH guidelines.
Ability to work both independently and collaboratively with internal and external team members.
Excellent oral and written communication skills, including effective scientific writing and presentation skills.
Strong organization, prioritization, and time-management skills.
Proficient with use of Microsoft Word, Outlook, Excel, MS Project and Powerpoint
Prior involvement in IND and NDA submissions.
Previous experience as a field monitor.
Scope
6 months with a strong possibility of renewal; Must be able to work onsite at the client.Estimated Salary: $20 to $28 per hour based on qualifications.
BioBridges, LLC
Overview
Our client is a biopharmaceutical company focused on the discovery and development of treatments for orphan and ultra-orphan disorders.
Their Clinical Divide
In order to keep their phase III program on track, need someone to help with study enrollment.
Project Details
This position is responsible for providing the scientific and operational expertise required to conduct clinical trials in accordance with appropriate regulatory requirements. Works as an integrated member of the clinical team to develop, implement, and manage clinical trial(s) from study design through close out. Manages relationships with external partners to ensure that timelines and deliverables are met.
Development of the clinical strategy, trial design and protocol development including:
Participating in the clinical research required for the study design (e.g. evaluating scientific literature, gathering investigator advice regarding current clinical practice(s) for the indication in question, etc.)
Contributing to the development of study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator Brochures (IBs) and other study-related documents as required.
Participating in estimating clinical study timelines using appropriate project management tools.
2. Manages relationships with one or more assigned investigator sites and vendors including facilitating and participating in budget development, contract negotiations and expenditure oversight.
3. Prepares investigator site lists and participates in their review and approval for inclusion in the study. Plans, coordinates and participates in investigator meetings including developing and presenting assigned sections of the meeting agenda/content.
4. Recommends strategies for and oversees the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency.
5. Conducts periodic review of clinical trial data to ensure timely, consistent and accurate data flow.
6. Presents project progress reports at internal team meetings and investigator meetings as required.
7. Working with appropriate team members, collects files and maintains study-related documents.
8. Participates in the submission of regulatory documents. This includes:
assists in the interpretation of clinical study results in preparation for inclusion in Clinical Study Reports (CSRs) and regulatory submissions
compiles and reviews assigned portions of reports for submission to regulatory agencies, Institutional Review Boards (IRBs), and scientific journals.
9. Addresses and resolves questions from sites and trial monitors regarding trial conduct.
Requirements
BS/BA in a related discipline and a minimum of 5 years of US and/or international experience in clinical research working for a pharmaceutical company or a contract research organization.
Comprehensive understanding of the drug developmental process.
Thorough knowledge of clinical trial design and operations.
Comprehensive knowledge of GCP and ICH guidelines.
Ability to work both independently and collaboratively with internal and external team members.
Excellent oral and written communication skills, including effective scientific writing and presentation skills.
Strong organization, prioritization, and time-management skills.
Proficient with use of Microsoft Word, Outlook, Excel, MS Project and Powerpoint
Prior involvement in IND and NDA submissions.
Previous experience as a field monitor.
Scope
6 months with a strong possibility of renewal; Must be able to work onsite at the client.Estimated Salary: $20 to $28 per hour based on qualifications.
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