Senior Clinical Research Specialist
Irvine, California, United States of America
Contract
20 hours ago
$62 USD
Key skills
RGoogle CloudECSLeadershipCommunicationTime Management
About this role
Kelly Science and Clinical FSP is currently seeking a Project Manager for a long-term engagement in Irvine, CA with one of our Global Medical Device clients. This position is hybrid. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time
FSP Intake Form
Required Info Client Name J&J MedTech - BWI Client Project Name for Bullhorn Kelly IOL/Client Lead Jackie Fraiser/Pam Kaplan Kelly Program Manager Katherine Lamia Kelly Program Coordinator Kyle Hamm Hiring Manager & Title Narvelle Delabaruere - Associate Director of Clinical Research Position Title Sr. Clinical Research Specialist Top 3 Required Skills
BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred Pay Rate (Hourly) 62.50 Bill Rate (Hourly) 104.18 Worksite Location Irvine, CA Remote Details (Remote Or Hybrid) Onsite T/TH/Every other Friday Travel Expectations 20% Travel will be all over the US sites, will have plenty of notice prior to travel. Is the HM willing to consider candidates open to relocation? (Are they open to paying a relocation fee for someone to be onsite) No Detailed Interview/Hiring Process MS Teams, video - 1-2 interviews of team members on Narvelle's team. MSA Status Executed Additional Detail (This will elevate the recruiting priority) Local candidates to Irvine only - no remote Internal notes for recruiting (i.e. position history, company culture, therapeutic area exp, system/software experience etc.): In your own words, how would you describe their normal routine: Must Have Site Mgmt - CRA experience Where is the client in the search/hiring process? Backfill for Michelle Ibarra What would entice an A+ candidate to take this job? *Paste Full JD in same box under the template
Job Description
Senior Clinical Research Specialist
SECTION 1: JOB SUMMARY*
This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
SECTION 2: DUTIES & RESPONSIBILITIES*
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for the ;
Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-Google Cloud Platform, applicable legislation and Company Standard Operating Procedures;
May serve as the primary contact for clinical trial sites (e.g. site management);
Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,....), ensure registration on from study initiation through posting of results and support publications as needed;
Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company
personnel;
Oversee the development and execution of Investigator agreements and trial payments;
Responsible for clinical data review to prepare data for statistical analyses and publications;
If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
May contribute to the development and delivery of appropriate global evidence generation
strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
Contribute to the critical assessment of the literature and to the interpretations and
disseminations of all evidence generated;
Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
Support project/study budget activities as assigned;
Develop a strong understanding of the pipeline, product portfolio and business needs;
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
Perform other duties assigned as needed;
Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations.
SECTION 3: EXPERIENCE AND EDUCATION*
Education
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Experience
BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.
Previous experience in clinical research or equivalent is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, Google Cloud Platform, ISO 14155, MDR, MEDDEV,...).
Clinical/medical background a plus.
Medical device experience highly preferred.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and
AFFILIATIONS*
Functional and Technical Competencies:
Good understanding of clinical research science and processes, clinical trends, and global
clinical trial regulations;
Proven track record in supporting delivery of clinical projects within clinical/ surgical research
setting, on time, within budget and in compliance to SOPs and regulations;
Good presentation and technical writing skills;
Good written and oral communication skills;
Leadership Competencies:
Ability to lead small study teams to deliver critical milestones, as may be assigned.
Leadership required in alignment with J&J Leadership Imperatives:
Connect - Develop collaborative relationships with key internal and external stakeholders.
Shape - Make recommendations for and actively participate in departmental process
improvement activities.
Lead - Take ownership in critical scientific thinking and development of self and engage in
transparent and constructive conversations.
Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget
and in compliance to SOPs and regulations.
Primary location for this position is Irvine. At management discretion, the position may be performed
remotely.
Ability to travel approximately 20% depending on the phase of the program.
SECTION 11: EXTERNAL INTERACTIONS ? This Section is Not Applicable
Frequent (several times per month) interaction with physicians and research staff at centers
selected for involvement in clinical research as well as those being evaluated.
May have regular interaction with third party vendors supporting clinical studies as applicable per
FSP Intake Form
Required Info Client Name J&J MedTech - BWI Client Project Name for Bullhorn Kelly IOL/Client Lead Jackie Fraiser/Pam Kaplan Kelly Program Manager Katherine Lamia Kelly Program Coordinator Kyle Hamm Hiring Manager & Title Narvelle Delabaruere - Associate Director of Clinical Research Position Title Sr. Clinical Research Specialist Top 3 Required Skills
- Preferred experience/background:
- Senior level, so good number of years' experience in clinical studies, at least 5 years
- Must Have: CRA experience (2 years)
- Site management experience, reviewing clinical data, ease and flexibility to get in and out of the database in regard to the reports. Safety experience
- Team needs an experienced professional who is able to work independently; over sees the monitors working with the team (2), very collaborative and previous experience working with a team.
- Medical device experience with cardiology or EP as a bonus
- Strong communication and time management skills
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, Google Cloud Platform, ISO 14155, MDR, MEDDEV,...).
- Clinical/medical background required
- Medical device experience highly preferred
- Would like candidate to occasionally help draft CRF's, help with study documentation.
BS with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred Pay Rate (Hourly) 62.50 Bill Rate (Hourly) 104.18 Worksite Location Irvine, CA Remote Details (Remote Or Hybrid) Onsite T/TH/Every other Friday Travel Expectations 20% Travel will be all over the US sites, will have plenty of notice prior to travel. Is the HM willing to consider candidates open to relocation? (Are they open to paying a relocation fee for someone to be onsite) No Detailed Interview/Hiring Process MS Teams, video - 1-2 interviews of team members on Narvelle's team. MSA Status Executed Additional Detail (This will elevate the recruiting priority) Local candidates to Irvine only - no remote Internal notes for recruiting (i.e. position history, company culture, therapeutic area exp, system/software experience etc.): In your own words, how would you describe their normal routine: Must Have Site Mgmt - CRA experience Where is the client in the search/hiring process? Backfill for Michelle Ibarra What would entice an A+ candidate to take this job? *Paste Full JD in same box under the template
Job Description
Senior Clinical Research Specialist
SECTION 1: JOB SUMMARY*
This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
SECTION 2: DUTIES & RESPONSIBILITIES*
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Serve as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for the ;
Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-Google Cloud Platform, applicable legislation and Company Standard Operating Procedures;
May serve as the primary contact for clinical trial sites (e.g. site management);
Contribute towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,....), ensure registration on from study initiation through posting of results and support publications as needed;
Management/oversight of ordering, tracking, and accountability of investigational products and trial materials;
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company
personnel;
Oversee the development and execution of Investigator agreements and trial payments;
Responsible for clinical data review to prepare data for statistical analyses and publications;
If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
May contribute to the development and delivery of appropriate global evidence generation
strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects;
If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
Contribute to the critical assessment of the literature and to the interpretations and
disseminations of all evidence generated;
Contribute to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
Support project/study budget activities as assigned;
Develop a strong understanding of the pipeline, product portfolio and business needs;
Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
Perform other duties assigned as needed;
Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but required guidance for complex situations.
SECTION 3: EXPERIENCE AND EDUCATION*
Education
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Experience
BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferred.
Previous experience in clinical research or equivalent is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, Google Cloud Platform, ISO 14155, MDR, MEDDEV,...).
Clinical/medical background a plus.
Medical device experience highly preferred.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and
AFFILIATIONS*
Functional and Technical Competencies:
Good understanding of clinical research science and processes, clinical trends, and global
clinical trial regulations;
Proven track record in supporting delivery of clinical projects within clinical/ surgical research
setting, on time, within budget and in compliance to SOPs and regulations;
Good presentation and technical writing skills;
Good written and oral communication skills;
Leadership Competencies:
Ability to lead small study teams to deliver critical milestones, as may be assigned.
Leadership required in alignment with J&J Leadership Imperatives:
Connect - Develop collaborative relationships with key internal and external stakeholders.
Shape - Make recommendations for and actively participate in departmental process
improvement activities.
Lead - Take ownership in critical scientific thinking and development of self and engage in
transparent and constructive conversations.
Deliver - Strive to ensure all deliverables on allocated studies are met on time, within budget
and in compliance to SOPs and regulations.
Primary location for this position is Irvine. At management discretion, the position may be performed
remotely.
Ability to travel approximately 20% depending on the phase of the program.
SECTION 11: EXTERNAL INTERACTIONS ? This Section is Not Applicable
Frequent (several times per month) interaction with physicians and research staff at centers
selected for involvement in clinical research as well as those being evaluated.
May have regular interaction with third party vendors supporting clinical studies as applicable per