Certified Clinical Research Coordinator

National Spine & Pain Centers•Winter Park, FL

About The Position

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 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.

Requirements

BLS Certified
IATA Certified

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.