Top 92 Clinical documentation specialist Jobs in La Jolla, Ca

Specialist, Clinical Trials
Neurocrine Bioscience —San Diego, CA
- $89,800 - $123,000 a year
- Full-time
- Psychiatry
- Computer literacy
- Bachelor of Science
- Paid holidays
- Health insurance
3d
Associate Specialist, Clinical Trials
Neurocrine Bioscience —San Diego, CA
- $35.35 - $47.34 an hour
- Full-time
- Psychiatry
- Computer literacy
- Bachelor of Science
- Paid holidays
- Health insurance
Clinical Documentation Improvement (CDI) Specialist - Onsite
Guidehouse Managed Services LLC —Escondido, CA
- $74,000 - $124,000 a year
- Full-time
- Medicine
- Anatomy knowledge
- Mid-level
- Health savings account
- Paid holidays
Senior Clinical Reimbursement Specialist
Veracyte —San Diego, CA
- $86,098 - $107,850 a year
- Email
- Remote
- Nursing
- Analysis skills
- Mentoring
Quick Apply
7d
Clinical Document Improvement Specialist II - Sharp Tri-City Medical Center
Sharp HealthCare —Oceanside, CA
- $57.00 - $75.21 an hour
- 8 hour shift
- Microsoft Word
- Nursing
- OSHA
3d
Clinical Trial Psych Rater - US Spanish Speaking
IQVIA —Carlsbad, CA
- $62,700 - $156,700 a year
- Part-time
- Remote
- Spanish
- Nursing
- Medicine
- Work from home
3d
Sr. Principal Specialist, Clinical Database Programming
Neurocrine Bioscience —San Diego, CA
- $158,100 - $216,000 a year
- Full-time
- Computer literacy
- Bachelor of Science
- Master's degree
- Paid holidays
- Health insurance
Director, Clinical Operations
Neurocrine Bioscience —San Diego, CA
- $190,500 - $260,000 a year
- Full-time
- Psychiatry
- Bachelor of Science
- Neurology
- Paid holidays
- Health insurance
Hospital Coder / Inpatient - Full Time
Sanford Health —San Diego, CA
- $22.50 - $36.00 an hour
- 8 hour shift
- Remote
- Background check
- Pass drug screening
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
11d
Medical Records Technician (Release of Information)
US Veterans Health Administration —San Diego, CA
- $51,871 - $67,432 a year
- Online Application
- Hybrid work
- Background check
- High school
- Pass drug screening
- Health insurance
7h
Clinical Data Specialist II
Alphatec Spine —Carlsbad, CA
- $85,000 - $98,000 a year
- Full-time
- Mid-level
- SQL
- Analysis skills
Quick Apply
RN Infusion Specialist
Finic Health Nursing —San Diego, CA
- $60 an hour
- Part-time
- Remote
- Background check
- CPR Certification
- Nursing
Quick Apply
4d
Manager, Nursing Informatics - Clinical Informatics
Rady Children's Health —San Diego, CA
- $82.14 - $112.94 an hour
- Nursing
- RN License
- System design
Clinical Relations Manager - Multiple levels
Glaukos —San Diego, CA
- $81,000 - $150,000 a year
- Full-time
- Background check
- Nursing
- Pass drug screening
Quick Apply
Clinical Trial Psych Rater - Hungarian Speaking
IQVIA —Carlsbad, CA
- Part-time
- Remote
- Nursing
- Medicine
- Psychiatry
- Work from home
6d
Certified Coder II
Neighborhood Healthcare —Escondido, CA
- $29.71 - $41.59 an hour
- Hybrid work
- HIPAA
- Clinic experience
- Mid-level
- Dental insurance
Quick Apply
6d
Sr. Specialist-Pharmacy Informaticist - Sharp System Pharmacy Services - Variable Shift - Full Time
Sharp HealthCare —San Diego, CA
- $83.97 - $121.36 an hour
- 8 hour shift
- Word processing
- Office
- Senior level
6d
Health Information Management Specialist II
Family Health Centers of San Diego —Chula Vista, CA
- $25.50 - $31.55 an hour
- Full-time
- Spanish
- Microsoft Outlook
- Computer literacy
- Vision insurance
Quick Apply
4d
Home Health Medical Billing and coding
Able Home Healthcare —San Diego, CA
- $20 - $25 an hour
- Full-time
- Mid-level
- Home Health
- Organizational skills
- 401(k)
- Paid time off
Quick Apply
4d
PACE Resource Management Registered Nurse
San Ysidro Health —San Diego, CA
- $50.29 - $66.27 an hour
- Full-time
- Nursing
- RN License
- Customer service
Quick Apply

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Specialist, Clinical Trials

Neurocrine Bioscience -
San Diego, CA

Apply Now

Job Details

Full-time
$89,800 - $123,000 a year
3 days ago

Benefits

Paid holidays
Health insurance
Dental insurance
Parental leave
Retirement plan

Qualifications

Research project management
Process improvement
Schedule management
ICH guidelines
Data interpretation
Computer skills
Clinical quality assurance standards
Clinical trial support in drug product development
Achieving project delivery timelines
Pharmaceutical research experience
Operations planning
FDA regulations

Full Job Description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)

About the Role:

Supports the operational activities for planning, initiation, conduct and close out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies. Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials. Collaborates with clinical research colleagues within Neurocrine, at Contract Research Organizations (CROs), and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety and impeccable documentation.

Your Contributions (include, but are not limited to):

Working with the Clinical Trial Managers (CTMs), helps ensure clinical studies are conducted in compliance with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies
Serves as a team member for of assigned clinical studies
Prepares data / information for technical and study design discussions
Provides administrative support, ensuring invoices are paid, tracking metrics, issues for CROs and other contract service providers (CSPs) for assigned studies
Participates in study team meetings and tracks study issues. Under direction of the CTM, creates study timelines in accordance with corporate goals. Helps with recruitment efforts
Participates in internally run studies including updating monitoring plans, documenting on-site monitoring guidelines, forms, tools and may participate in onsite monitoring and co-monitoring visits, as necessary
Works collaboratively within clinical operations in documenting NBI standard processes across clinical programs
Develops relationships with investigator sites, IRBs/IECs, and CROs to ensure trial needs and requirements are met
Collaborates with CTM and fellow team members to expedite study start up processes for trials and to resolve quality issues with documents
Pre-populates essential document templates and creates essential document packets
Coordinates site essential document collection for assigned studies and maintain complete and accurate essential documents for the duration of the study
Performs IRB/IEC study level submissions and manages site submissions to ensure IRB/IEC compliance throughout assigned trials
Participates in team meetings by providing clinical document and IRB/IEC status updates to the ClinOps team
Develops Consent Documents (CDs), and reviews site CDs following regulatory requirements and NBI SOPs
Manages document translation process with vendors
Manages distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs
Supports study monitors by providing updates regarding outstanding documents and addressing eTMF or IRB/IEC related questions
Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the eTMF system. Works with the NBI and/or the CRO study team to resolve eTMF QC findings and ensure the eTMF QC is documented
Ensures eTMF QC is performed according to the schedule outlined in the TMF Plan, if available
Other duties as assigned

Requirements:

BS/BA in Scientific field or equivalent AND 2+ years of clinical trials or operations experience, CRO/Vendor Management exposure is preferred. Participation in monitoring clinical trials or related experience preferred. OR
Master's degree in Scientific field or equivalent AND Some experience as noted above
Working knowledge of clinical drug development process including working knowledge of ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive
Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out.
Some trial management protocol and process knowledge
General understanding of Clinical Research industry and the relevant environments in which it operates
Ability to plan activities and works well under changing circumstances; manages time effectively
Has some knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
Works to improve tools and processes within functional area
Ability to work as part of a team
Strong computer skills
Good communications, problem-solving, analytical thinking skills
Sees impact on department
Ability to meet multiple deadlines across a project/program, with a high degree of accuracy and efficiency
Developing project management skills
Ability at analyzing data and information to derive options/recommendations for management considerations

#LI-RS1

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $89,800.00-$123,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Apply Now

Refine Your Search

clinical documentation specialist jobs in la jolla, ca

Specialist, Clinical Trials

Associate Specialist, Clinical Trials

Clinical Documentation Improvement (CDI) Specialist - Onsite

Senior Clinical Reimbursement Specialist

Clinical Document Improvement Specialist II - Sharp Tri-City Medical Center

Clinical Trial Psych Rater - US Spanish Speaking

Sr. Principal Specialist, Clinical Database Programming

Director, Clinical Operations

Hospital Coder / Inpatient - Full Time

Medical Records Technician (Release of Information)

Clinical Data Specialist II

RN Infusion Specialist

Manager, Nursing Informatics - Clinical Informatics

Clinical Relations Manager - Multiple levels

Clinical Trial Psych Rater - Hungarian Speaking

Certified Coder II

Sr. Specialist-Pharmacy Informaticist - Sharp System Pharmacy Services - Variable Shift - Full Time

Health Information Management Specialist II

Home Health Medical Billing and coding

PACE Resource Management Registered Nurse

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