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Eastern Virginia Medical School · 10 hours ago

Coordinator Clinical Research (Non-RN)

US-VA-Norfolk

Full-time

Onsite

Mid, Senior Level

$72K/yr - $72K/yr

5+ years exp

Eastern Virginia Medical School is seeking a Clinical Research Coordinator to manage daily operations of clinical trials and studies. The role involves acting as a key link between investigators, study participants, and sponsors, ensuring studies run smoothly and ethically through participant recruitment, data collection, and regulatory documentation.

Higher Education

H1B Sponsor Likely

Responsibilities

Manage studies per FDA, GCP and ICH regulations following the guidelines that apply

Develop Informed Consents, obtain informed consent and assure that anyone listed on the study delegated to obtain consent is doing so per regulations and that consent is documented appropriately and maintained per SOPs for review

Develop source documents, complete as needed and review and document where and how source was obtained

Develop case report forms for investigator-initiated studies

Enter data on study specific electronic databases or case report forms

Complete data collection for clinical trials

Review medical records and assemble and clarify data required

Complete study screening and recruitment for all assigned clinical trials

Respond to sponsor inquiries and requests

Responsible for contributing to Clinical Research SOPs

Prepare for and facilitate internal, external, and FDA study audits

Attend various conferences, both by phone and central meeting with other centers and sponsors pertaining to current or proposes studies

Respond to sponsor site questionnaires and conduct site evaluation visits as needed, providing updated patient demographics and area census information

Complete documentation in case report forms; develop and maintain study specific source documents

Work with study sponsor and monitors to resolve queries in a timely manner or in the timeframe required by the sponsor

Facilitate the collection of biological samples, including drawing blood, process, prepare store or ship as required and maintain log book

Assist with ordering study supplies

Provide pricing of study procedures and supplies as needed for development of budgets, along with T&E of staff being charged to study

Coordinate pre-study start up, interfacing with scheduling, billing, health services and other required areas. Continue communication with all areas to update on study status

Responsible for the reporting of all Adverse Events, Serious Adverse Events, Unanticipated Problems, and Protocol Deviations (IRB, CRO and sponsor submissions) in accordance with timeline and requirements of IRB and Sponsor

Review clinical patient appointment schedules for possible eligibility of participants in clinical studies and communicate with providers about potential research patients on their schedules

Maintain required certifications (i.e. BBP, HIPAA, IATA, GCP)

Assist Regulatory Coordinator in maintaining clinical study regulatory files (all correspondence for regulatory files, obtains and delivers IRB correspondence, etc.)

Assist Regulatory Coordinator with Institutional Review Board submissions and follow-up, including amendments, continuing reviews, ensuring PI signature both electronic and paper

Maintain and acquires updated lab certifications, CLIA certificates for laboratories utilized by studies at HH, Riverside, and Princess Ann offices. Maintains scanned copies accessible via the computer

Maintain and acquires copies of all training required for research investigators and their staff, genetic counselors, and Ultrasonographers, other staff, fellows, residents and students listed on studies, updated CVs and licenses for all study staff for files, regulatory binders and forwarding to sponsors. Maintains scanned copies accessible via the computer

Act as a resource for helping staff obtain and maintain required research training

Maintain files of computerized standard letters and forms for study specific needs and correspondence

Compile reports using Power Point (or related software)

Responsible for keeping study activity updated in computer files and regulatory binders

Handle transmission and receipt of faxes, FedEx and UPS mail between sponsors and site

Arrange meetings and meeting rooms as required

Provide interdepartmental support as needed

Other duties as assigned requested or required

Qualification

Clinical research managementRegulatory complianceData collectionInformed consent developmentStudy participant recruitmentClinical trial documentationPatient assessmentInterdepartmental supportOrganizational skillsCommunication skills

Required

Ability to think and work independently

Insight

Excellent organizational skills

Astute and accurate patient assessment skills

Ability to identify and assign priorities

Preferred

Bachelor's degree in science related field

Five (5) years of clinical research experience

Company

Eastern Virginia Medical School

Eastern Virginia Medical School is a school in Norfolk.

Founded in 1964

Norfolk, Virginia, USA

1001-5000 employees

http://www.evms.edu/

H1B Sponsorship

Eastern Virginia Medical School 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

2024 (9)

2023 (12)

2022 (10)

2021 (13)

2020 (3)