Certified Clinical Research Coordinator at National Spine And Pain Centers LLC

Winter Park, Florida, United States -

Full Time

Start Date

Immediate

Expiry Date

25 May, 26

Salary

0.0

Posted On

25 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

FDA Inspections, Clinical Research, Protocol Management, Budget Management, Recruitment, Study Start-up, Good Clinical Practice, Informed Consent, eCRF Completion, EMR Charting, Regulatory Compliance, IRB Submissions, Device Accountability, Monitor Visits, HIPAA, BLS Certified

Industry

Medical Practices

Description

Duties and Responsibilities • Maintain successful FDA site inspections • Work closely with Principle Investigator on all study related material and strategic plans i.e. Protocol, CTA/CSA, Budget, Recruitment, Site preparation, Site feasibility, Study start up, Study closure • Good Clinical Practice – CITI training/NIH Training • Recruit/Screen subjects • Conduct informed consent process • Evaluate inclusion/exclusion criteria • Collect patient demographics and obtain medical records • Coordinate subject appointments as required per study timeline. Schedule subject appointments, procedures, laboratory testing • Complete study questionnaires and administer subject questionnaires. • Complete and correct eCRF’s • Transcribe and ensure subject EMR charts for accuracy • Maintain and store source documents • Regulatory i.e. update and maintain binder, IRB submissions and contact, sponsor contact • Device/Drug Accountability • Attend and assist monitor/sponsor visits • Attend investigator meetings as required • Handle confidential Information and correspondences • Manage and maintain heavy calendar/schedule/travel arrangements • Track expenses and submit for reimbursement • Organize business meetings and professional lectures • Prepare materials needed for meetings/lectures • Adhere to and uphold all applicable federal and state compliance regulations as well as NSPC’s Code of Conduct and Employee Handbook, compliance policies and procedures, and applicable healthcare fraud, waste and abuse laws. • Annual completion of compliance training • Reporting issues • Other duties as assigned • Adhere to and uphold all applicable federal and state compliance regulations, the NSPC Code of Conduct, the NSPC Employee Handbook, compliance policies and procedures, and applicable healthcare fraud, waste and abuse laws. • Ensure adherence to all compliance standards among all NSPC colleagues and staff, including those managed or overseen. • Understand, comply with, and enforce all NSPC policies, procedures, codes of conduct, and OSHA and HIPAA privacy rules. • All other duties, as assigned. Qualifications and Skills • BLS Certified • IATA Certified Working Conditions • Located in a fast-paced, professional office environment with a noise level that is generally moderate. • Regular use of standard office equipment (including computers, phones, photocopiers, filing cabinets, fax machines, etc.). • Ability/flexibility to travel, as needed. Physical Requirements • Extensive and regular periods of sitting, standing, bending, walking, seeing, talking, and listening. • Adequate visual acuity including ability to read information. • An occasional requirement to reach with hands/arms, stoop, kneel, or crouch. • An occasional requirement to push, pull, lift and/or move up to 10 pounds.

Responsibilities

The Clinical Research Coordinator is responsible for maintaining successful FDA site inspections and collaborating closely with the Principal Investigator on all study materials, including protocols, budgets, and recruitment strategies. Key duties involve subject screening, conducting informed consent, managing study timelines, completing case report forms, and maintaining regulatory documentation.