What are the responsibilities and job description for the Clinical Research Scientist - BWI position at Integrated Resources, Inc?
Clinical Research Specialist
Location: Irvine, CA Hybrid
Duration: Long term role with Benefits (1 year with possible extension)
This position is hybrid located in Irvine, CA
Job Description:
This professional will report to Clinical Science and External Research Leaders in the management of assigned clinical projects for the cardiovascular Group including development of evidence generation strategy, clinical study management, publication management and execution, and literature review.
S/he will manage activities with supervision consistent with level of experience.
S/he will be responsible for providing support activities for clinical activities & other study-related tasks, as well as applicable department study-related procedures.
The Senior Clinical Research Scientist will or may be responsible for:
Working with Research Leaders for preclinical/clinical research activities and drive Evidence Generation Strategy.
Communicate progress towards planned timelines.
Work with Global Strategic Marketing, Franchise Clinical Leaders, Biostatistics, Data Management, Medical Affairs and other functions on physicians research collaborations, study idea development and progress, and data dissemination via publication and congress planning.
Develop study-related materials (e.g. protocol)
Perform assigned sub-project tasks with cardiovascular group clinical staff.
Perform clinical operation tasks (e.g. contracting, payments) associated with assigned projects
Provide accurate, up-to-date project knowledge as requested by key stakeholders.
Track assigned project budgets to ensure adherence to business plans.
Analyze, interpret and disseminate appropriate interpretation of evidence generated from research studies
Lead study-related publication effort including abstracts and manuscripts, per clinical publication policy.
Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel.
Provide quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies.
Know, understand, incorporate, and comply with all applicable laws and regulations relating to CSS business activities, and Policies and Procedures.
Evaluating support requests for publications and to provide consolidated comments and support to the requests.
Additional Skills Requirements:
Project management, organizational and presentation skills
Self-motivated
Written and oral communication skills
Proficient in Microsoft Office
Qualifications:
A minimum of a Bachelor s Degree with at least 5 years of clinical research or related technical experience required.
Advance degree (master, PhD, PharmD etc.) with 0-1 year of clinical or related research experience highly preferred
A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
The ability to influence others along with strong written and oral communication skills is required.
Knowledge of Good Clinical Practices is required.
Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics related healthcare market environment and global clinical trial regulations is preferred.
Prior experience in systematic literature review and publications highly preferred
Project management skills with the ability to handle multiple projects required.
Medical device experience is preferred.
Cardiovascular experience is a plus
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
Location: Irvine, CA Hybrid
Duration: Long term role with Benefits (1 year with possible extension)
This position is hybrid located in Irvine, CA
Job Description:
This professional will report to Clinical Science and External Research Leaders in the management of assigned clinical projects for the cardiovascular Group including development of evidence generation strategy, clinical study management, publication management and execution, and literature review.
S/he will manage activities with supervision consistent with level of experience.
S/he will be responsible for providing support activities for clinical activities & other study-related tasks, as well as applicable department study-related procedures.
The Senior Clinical Research Scientist will or may be responsible for:
Working with Research Leaders for preclinical/clinical research activities and drive Evidence Generation Strategy.
Communicate progress towards planned timelines.
Work with Global Strategic Marketing, Franchise Clinical Leaders, Biostatistics, Data Management, Medical Affairs and other functions on physicians research collaborations, study idea development and progress, and data dissemination via publication and congress planning.
Develop study-related materials (e.g. protocol)
Perform assigned sub-project tasks with cardiovascular group clinical staff.
Perform clinical operation tasks (e.g. contracting, payments) associated with assigned projects
Provide accurate, up-to-date project knowledge as requested by key stakeholders.
Track assigned project budgets to ensure adherence to business plans.
Analyze, interpret and disseminate appropriate interpretation of evidence generated from research studies
Lead study-related publication effort including abstracts and manuscripts, per clinical publication policy.
Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel.
Provide quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies.
Know, understand, incorporate, and comply with all applicable laws and regulations relating to CSS business activities, and Policies and Procedures.
Evaluating support requests for publications and to provide consolidated comments and support to the requests.
Additional Skills Requirements:
Project management, organizational and presentation skills
Self-motivated
Written and oral communication skills
Proficient in Microsoft Office
Qualifications:
A minimum of a Bachelor s Degree with at least 5 years of clinical research or related technical experience required.
Advance degree (master, PhD, PharmD etc.) with 0-1 year of clinical or related research experience highly preferred
A Life Science, Physical Science, Nursing, or Biological Science degree is preferred.
The ability to influence others along with strong written and oral communication skills is required.
Knowledge of Good Clinical Practices is required.
Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics related healthcare market environment and global clinical trial regulations is preferred.
Prior experience in systematic literature review and publications highly preferred
Project management skills with the ability to handle multiple projects required.
Medical device experience is preferred.
Cardiovascular experience is a plus
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
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