Clinical Trial Assistant

Location:  San Rafael, California Category: Clinical Employment Category: Fulltime-Temporary

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 
 

OVERVIEW:

BioMarin Clinical Operations

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.

 

BioMarin’s Development Sciences Operations (DSO) group is responsible for everything from research and discovery to post-market clinical development. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

 

BioMarin’s Clinical Operations group ensures proper planning, conduct, monitoring and data quality from study start-up to close-out. The group is responsible for fostering effective communication and collaboration between study sites and BioMarin.

 

SUMMARY DESCRIPTION

The Clinical Trial Assistant (CTA) performs essential responsibilities for successful trial execution at BioMarin. The CTA assists with the coordination of activities associated with the start-up, management, and close-out of clinical studies under the direction the Clinical Operations team. This may include assisting with study matters that impact study timelines, quality and budget.

                                                                                                                                               

 

KEY RESPONSIBILITIES:

The Clinical Trial Assistant can be partly or fully responsible for the following areas depending on his/her level of proficiency. Responsibilities may include, but are not limited to:

 

Quality:

·         Create/maintain essential document trackers

·         Conduct comprehensive review, as per Trial Master File (TMF) Plan

·         Provide continuous input to electronic Trial Master File (eTMF) content list

·         Assist with Clinical Operations internal filing of study documents in Livelink/O365 and eTMF

 

Contracts & Budgets:

·         Facilitate the initiation and maintenance of the Clinical Trial Agreements, non-disclosure agreements, contract execution, vendor purchase orders, and miscellaneous study requests in Spring CM, as needed

 

Clinical Operations Managed Vendors & CRO:  

·         Reconciliation & management of key documents (plans, site contact list, etc.)

·         Assist in any purchase order (PO) related inquiries

·         Assist in any subject travel inquiries, escalations, or exceptions

·         Ensure vendor PO contains funds for insurance and translation vendors

·         Ensure invoice management for insurance and translations if required

 

Protocol & Informed Consent Form (ICF) Development Process:

·         Ensure ICF form sign offs are filed in eTMF for all local ICFs

·         Ensure appropriate versioning and tracking for countries and sites

 

Study Start Up:

·         Provide administrative assistance with internal and external meetings including investigator meeting(s)

·         Assist in the preparation of investigator meeting materials

·         May arrange study specific printing (mini-protocols)

·         Request and distribute insurance policy/certificates (see Insurance section)

·         Facilitate Screening Authorization Forms tracking/sign off when applicable

·         Assist with Investigational Product (IP) Pack Release form review quality control checks

·         Manage various Clinical Operations document translations

·         Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF)

·         Process documents for signature in DocuSign

·         Ensure accurate study entry and updates to ClinicalTrials.gov as delegated by the Clinical Trial Specialist (CTS)

 

Study Conduct and Close-out:

·         Ensure MVR tracking and filing of sponsor comments

·         Identify issues, with potential resolution, and escalate to the Study Specialist/SOL

·         Assist in the conduct of study close-out activities (sites, reconciliation activities, filing & archiving)

·         Track and collate clinical trial documentation related to CSR appendices

 

Insurance:

·         Request and coordinate written approval for country insurance policies, site specific certificates, and their updates

·         Ensure appropriate distribution and archiving of policies and certificates

·         Track insurance expiry dates

·         Initiate extensions of expiring policies and processing of certificates, as appropriate

 

Drug or Investigational Product (IP):

·         Assist in IP related task as requested by the Clinical Operations team

·         Assist in managing ancillary supplies including at vendor/sites

 

Clinical Governance / Team Membership:

·         Attend internal Clinical Operations team meeting and sub team meeting(s) and take meeting minutes as required

 

 


COMPETENCIES

The Clinical Trial Assistant is expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Analysis, Problem solving and Decision Making. For example:

·         Responds promptly with clear, organized written and oral communication

·         Takes ownership and accountability for completing assigned tasks and perseveres through obstacles

·         Embraces new challenges or changed priorities and adjusts plans and priorities accordingly

The Clinical Trial Assistant is also in the process of developing foundational technical competence in Compliance and Quality and Drug Development and Study Design.

 

CAREER DEVELOPMENT

BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Clinical Operations has been defined and is available to employees of BioMarin.

 


PEOPLE MANAGEMENT

No people management responsibilities

 

EDUCATION AND EXPERIENCE

BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered.

1 year pharmaceutical industry experience

 

WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL

The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 20 lbs. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.

Some travel may be required.

 

EQUIPMENT

Computer work utilizing common business software programs and hardware solutions.

 

 

CONTACTS

Internal: Clinical Operations team and Study Execution Team Members, Core Team personnel, GCP Compliance, other Clinical Operations personnel; Other BioMarin Worldwide Research and Development functional area personnel; BioMarin Senior Management

 

External: CRO personnel, other vendor personnel, counterparts or appropriate team members at partner companies, clinical sites


 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.