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Advanced Clinical · 13 hours ago

Senior Clinical Research Associate - Fixed Term

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. They are seeking a Senior Clinical Research Associate who will be responsible for conducting monitoring activities at assigned clinical trial sites and ensuring compliance with study protocols and regulatory requirements.

BiotechnologyConsultingHealth CareInformation TechnologyPharmaceuticalStaffing Agency

Culture & Values

H1B Sponsor Likely

Hiring Manager

Chris Thomas

Responsibilities

Conducting monitoring activities at assigned clinical trial site(s)

Verifying the adequacy, reliability, and quality of data collected at clinical sites

Ensuring the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries

Subject safety, data integrity, and protecting the subject confidentiality

Mentoring CRAs and other Clinical Operations (CO) staff

Anticipating, recognizing and resolving issues in the served study sites and may oversee such activities of CRA/other CO staff

Follows and ensures assigned studies are conducted in compliance with the currently approved Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs), Code of Federal Regulations (CFR), Good Clinical Practice (ICH GCP), and local or country regulations

Participates in Investigator feasibility and selection process by contacting sites to obtain feasibility information

Conducts site qualification (pre-study), site initiation, routine interim and close-monitoring visits for assigned studies and sites

Travels to research sites to conduct on-site visits as required

Prepares site submissions to the Independent Ethics Committees (central and local) and to Competent/Regulatory Authorities, when applicable

Assists with the development of Investigator and Institution contracts and budget templates, negotiates site budgets, and arranges site payments, when applicable

Attends internal CRA Team meetings and participates in study team and sponsor meetings, as required

Participates in Investigator meetings and assists with meeting preparation, when required

Conducts monitoring visits per the monitoring visit frequency defined in the Monitoring Plan or as instructed by the study team and confirms visit attendance by sending visit confirmation letters to site staff

Manages his/her own monitoring visit schedule for all assigned sites in accordance to the Monitoring Plan or the study needs

Proactively schedules appointments to meet with site staff during monitoring visits

Verifies that all delegated study staff at assigned sites are trained/certified and maintain compliance with requirements of the study protocol, informed consent process, data collection requirements, Investigational Product/Investigational Medical Device (IP/IMP) accountability/supply management, and safety reporting requirements

Ensures the adequacy, reliability, and quality of all study data at assigned sites by performing source data review, source document verification, query resolution, and regulatory document and investigational product review

Ensures that each assigned site is equipped with all necessary study equipment and supplies, and that the procedures (including sampling, processing, storage and shipment logistics) are appropriately adhered to

Ensures subject safety, data integrity, and subject confidentiality

Writes monitoring visit reports (MVRs) and sends site visit follow-up letters (FUL) as outlined in SOPs and study Monitoring Plans

Routinely reviews the Investigator Site File (ISF) and the Pharmacy Binder (if applicable) for accuracy, timeliness and completeness

Reconciles the Investigator Site File (ISF) with the Trial Master File (TMF) and uploads any documents obtained during monitoring visits to the TMF to ensure inspection readiness at all times

Maintains awareness of key study performance indicators via regular communication with the site and clinical study team including Investigators, study coordinators, pharmacist, and other study personnel

Discusses study status, timelines, patient recruitment, screening, enrollment, and retention efforts, ongoing patient status, IP/IMP supplies, study supplies, and any further requests or issues with each assigned site

Conducts routine follow-up of open action items between monitoring visits to ensure timely closure

Creates and maintains study/site trackers to successfully conduct monitoring visits

Provides project specific training, mentoring, and/or co-monitoring with new CRAs

Completes assigned function area and study specific trainings

Performs other duties as assigned per Advanced Clinical needs

Qualification

Clinical monitoringDrug development processRegulatory requirementsMS Office proficiencyCommunication skillsInterpersonal skillsOrganizational skillsAttention to detail

Required

Must have 3-5 years of clinical monitoring experience

The ideal candidate should have a Bachelor's degree in life sciences, a nursing degree, or be able to demonstrate equivalent experience

Ability to travel up to an average of 80%, depending on project needs

Must demonstrate clear understanding of the drug development process, clinical monitoring, and safety and regulatory requirements

Must have excellent verbal and written communications skills as well as excellent interpersonal, presentation, and organizational skills with demonstrated attention to detail

Must be able to work independently and in a team environment

Must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum

This role may be office and/or home-based however regular infrequent visits to a Company office will also be required

Company

Advanced Clinical

Advanced Clinical is a pharmaceuticals company offering CRO, FSP, quality, and validation services.

Founded in 1994

Deerfield, Illinois, USA

501-1000 employees

http://advancedclinical.com

H1B Sponsorship

Advanced Clinical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (8)

2024 (4)

2023 (1)

2022 (3)

2021 (5)

2020 (8)