Senior Clinical Research Specialist

3 months ago

Irvine, United States Kelly Science, Engineering, Technology & Telecom Full time

Join Kelly FSP as a Senior Clinical Research Specialist with this hybrid role at our Client Site in Irvine, CA


Hybrid: On site Monday, Wednesday and every other Friday.


Job Description


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.

DUTIES & RESPONSIBILITIES*

Under general direction and in accordance with all applicable federal, state and local laws/regulations, 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.

Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, 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 www.clinicaltrials.gov 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.


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, GCP, ISO 14155, MDR, MEDDEV,…).

Clinical/medical background a plus.

Medical device experience highly preferred.


Functional and Technical Competencies:

  1. Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;
  2. 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;
  3. Good presentation and technical writing skills;
  4. 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 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.



LOCATION & TRAVEL REQUIREMENTS

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.


EXTERNAL INTERACTIONS

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 program.

  • Clinical Research Coordinator

    2 weeks ago

    Irvine, California, United States Irvine Clinical Research Full time

    About the Role: We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team at Irvine Clinical Research. As a Research Assistant, you will provide administrative support to our team of physicians, psychologists, and research coordinators. This position is ideal for an ambitious individual who is willing to start at an...

  • Clinical Research Specialist

    1 month ago

    Irvine, United States Kelly Science, Engineering, Technology & Telecom Full time

    Join Kelly FSP as a Clinical Research Specialist with our Medical Device client in Irvine, CAThis is a hybrid position Tuesday/Thursday and every other Friday on site. RESPONSIBILITIESServes as a Clinical Research Specialist within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device...

  • Clinical Research Specialist

    2 months ago

    Irvine, United States Kelly Science, Engineering, Technology & Telecom Full time

    Join Kelly FSP as a Clinical Research Specialist with our Medical Device client in Irvine, CAThis is a hybrid position Tuesday/Thursday and every other Friday on site. RESPONSIBILITIESServes as a Clinical Research Specialist within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device...

  • Clinical Research Nurse Specialist

    3 weeks ago

    Irvine, California, United States Keck School of Medicine Full time

    About the RoleWe are seeking a skilled Clinical Research Nurse Specialist to join our team at the Keck School of Medicine. As a key member of our research team, you will play a critical role in supporting clinical researchers across our institution.The successful candidate will have a strong background in nursing and experience in conducting clinical...

  • Per Diem Clinical Research Nurse Specialist

    3 weeks ago

    Irvine, California, United States Keck School of Medicine Full time

    The University of Southern California's Keck School of Medicine is a world-class research institution.Salary: $48.50 - $52.00 per hour, based on relevant experience.Job Overview: We are seeking a highly skilled and dedicated Per Diem Clinical Research Nurse Specialist to join our team.Key Responsibilities:Assist investigators and research teams in conducting...

  • Academic Neurology Specialist

    3 weeks ago

    Irvine, California, United States Pacific Companies, Inc. Full time

    Seeking a highly skilled Academic Neurology Specialist to join our team at the University of California, Irvine. As a member of our esteemed department, you will have the opportunity to contribute to groundbreaking research and clinical practice in Neurology Memory Disorders.Overview: Our program is committed to advancing the understanding and treatment of...

  • Clinical Research Nurse Specialist

    3 weeks ago

    Irvine, California, United States City of Hope Full time

    At City of Hope, a national leader in cancer care and medical research, we're committed to delivering the cures of tomorrow to the people who need them today.As a Clinical Research Nurse, you'll be part of a transformative team that's changing lives. We're growing our national system with new clinical care locations across Southern California, a cancer...

  • Senior Clinical Research Associate

    3 weeks ago

    Irvine, United States Kelly Full time

    Job DescriptionSenior Clinical Research Associate - West CoastKelly Science and Clinical FSP is currently seeking a Senior Clinical Research Associate for a long-term engagement in the US with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit...

  • Clinical Research Biostatistics Leader

    3 weeks ago

    Irvine, California, United States Edwards Lifesciences Full time

    About This OpportunityAs a Senior Manager, Biostatistics at Edwards Lifesciences, you will play a crucial role in leading clinical research initiatives that drive innovation and improve patient outcomes.Key ResponsibilitiesLead biostatistical teams in the design, analysis, and presentation of clinical studies for pivotal trials.Oversee activities to ensure...

  • Healthcare Researcher

    6 days ago

    Irvine, California, United States University Of California Irvine Full time

    The University of California, Irvine is seeking a talented researcher to join its esteemed team in the Department of Radiology. As a Junior or Assistant Specialist, you will be instrumental in assisting faculty with research investigations, contributing to the advancement of healthcare services.This role offers an exceptional opportunity to work on various...

  • Senior Care Specialist

    3 weeks ago

    Irvine, California, United States Kisco Senior Living Full time

    Estimated salary for this role is $20,000 - $25,000 per year.About the RoleThe Senior Care Specialist at Kisco Senior Living is responsible for providing exceptional care to our residents. This role requires a high level of compassion, empathy, and understanding of the needs of older adults.Key ResponsibilitiesAssist residents with daily living activities...

  • Oncology Clinical Research Nurse Specialist

    3 weeks ago

    Irvine, California, United States City of Hope Full time

    Transformative Care for Patients with Life-Threatening IllnessesCity of Hope is a renowned healthcare organization dedicated to delivering innovative treatments and cures for cancer, diabetes, and other life-threatening diseases. As a Clin Research Nurse, you will play a vital role in our mission to make a real difference in the lives of our patients.About...

  • Sr Clinical Research Scientist/Medical Writer

    3 weeks ago

    Irvine, United States Kelly Science, Engineering, Technology & Telecom Full time

    Senior Clinical Research Scientist/ Medical WriterQualifications:A minimum of a Bachelor’s degree with at least 5 years of clinical research experience requiredAdvance degree (Master’s degree, PhD, PharmD etc.) with 2-3 year of clinical or related research experience highly preferredA Life Science, Physical Science, Nursing, or Biological Science degree...

  • Senior Clinical Manager

    3 weeks ago

    Irvine, United States Elevate Search Full time

    Elevate Search is partnering with a class III medical device company to find a Senior Manager, Clinical Affairs for it's growing team. This is a new position due to company growth. The best person for this role will have a solid blend of leadership skills and a "get your hands dirty in the trenches" mentality. This person must have experience with the...

  • Senior Family Law Specialist

    3 weeks ago

    Irvine, California, United States Kastel Staffing Full time

    Job Overview">Kastel Staffing is seeking a seasoned Senior Family Law Specialist to join our team. This is an excellent opportunity for a highly motivated and experienced attorney to work on complex family law cases, collaborate with colleagues, and leverage their expertise to deliver exceptional results.">About the Role">This position offers a competitive...

  • Research & Clinical Investigator

    3 weeks ago

    Irvine, United States Arbonne Full time

    We are seeking a Research & Clinical Investigator passionate about ensuring the sound science of our nutrition and personal care products, along with developing relevant and meaningful products that address key customer needs in the global health and wellness space.If you have a passion for health and wellness (nutrition and personal care), and would enjoy...

  • Senior Neurology Specialist

    3 weeks ago

    Irvine, California, United States Pacific Companies, Inc. Full time

    Role SummaryWe are seeking a skilled Senior Neurology Specialist to join our esteemed academic program in California. This is an excellent opportunity for a talented physician to grow professionally, contribute to innovative research, and lead in the field of Neurology Memory Disorders.

  • Research Coordinator

    3 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    Job OverviewWe are seeking a highly skilled Research Coordinator to support our clinical trials efforts. The successful candidate will have excellent communication and organizational skills, with the ability to work effectively in a team environment.

  • Sr Clinical Research Scientist/Medical Writer

    3 weeks ago

    Irvine, United States Kelly Full time

    Job DescriptionSenior Clinical Research Scientist Qualifications: \tA minimum of a Bachelor’s degree with at least 5 years of clinical research experience required \tAdvance degree (Master’s degree, PhD, PharmD etc.) with 2-3 year of clinical or related research experience highly preferred \tA Life Science, Physical Science, Nursing, or Biological...

  • Research Scientist Specialist

    6 hours ago

    Irvine, California, United States University Of California Irvine Full time

    Job OverviewThe University of California, Irvine is seeking highly motivated and skilled researchers to join our team in the Department of Neurology. As a Junior Neurology Specialist, you will work alongside experienced professionals to investigate the mechanisms and neurobiological basis of coma, stroke, and brain-heart-lung interactions.Key...