Careers

Human Resources:

Maria Aleman
Human Resources Manager
Phone: (727) 344-7602, ext. 3808
E-mail: careers@hill-top.com


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Job Description

Quality Control Coordinator - Memphis, TN

Reports to: Site Director


FLSA Status: Non-Exempt – clerical duties


Primary Responsibility:

To assess, identify and maintain processes and procedures that ensure compliance with the study protocol, applicable regulatory requirements, quality standards, country/state specific laws and Consumer Center Standard Operating Procedures (SOPs).


Job Duties:

  • Assists the Site Director/Study Coordinator in the review of protocols, informed consents, and all study-related documents, as requested, to provide consistency, accuracy and accountability.
  • Maintains a working knowledge of current SOPs to ensure proper adherence by site staff.
  • Attends study review meetings.
  • Hosts client/sponsor audits.
  • Provides documentation in preparation for regulatory inspections.
  • Implements and maintains professional working relationships with the site staff.
  • Increases working knowledge of regulations, quality standards and country/state-specific laws and implements in day-to-day auditing activities.
  • Successfully creates and implements formal presentations/training of other associates as assigned.
  • Reviews reports from statistician for errors in statistical calculations, noncompliance and inconsistencies.
  • Reviews prepared study summaries and reports to ensure that data are reliable, accurate and complete.
  • Ensures that all findings reach resolution by affected employee.
  • Reports common/continuing issues to Site Director.
  • Coordinates the quality control effort at the site.
  • Trains associates on proper and effective quality control techniques.
  • Reviews quality control efforts of other associates.
  • Reviews completed study documentation for completeness and accuracy, as well as protocol and SOP adherence.

Qualifications:

Four-year degree in a Science or related field is required.

Skills and Abilities:

  • Ability to accurately review and evaluate study protocols, informed consents, source documents, case report forms, adverse event reports, etc. and make evaluative judgments.
  • Ability to organize and readily retrieve study documentation, as needed.
  • Knowledge of data collection techniques and records maintenance.
  • Ability to investigate and analyze information and to draw conclusions.
  • Demonstrated knowledge of Consumer Center SOPs/policies, regulatory requirements and quality standards.
  • Demonstrated ability to conduct quality control and data binder reviews and to communicate findings to the Site Director.
  • Ability to assist the Site Director with sponsor audits, as needed.
  • Ability to edit and write reports pertaining to quality control information as required by the Site Director.
  • Ability to conduct quality control training, as needed, for site associates.
  • Ability to communicate effectively, both orally and in writing.
  • Ability to effectively interact with the Site Director and site associates.
  • Knowledge of relevant scientific/medical terminology.
  • Ability to work independently and prioritize tasks and projects.
  • Ability to achieve individual, team and site goals.
  • Must be adept in the use of Microsoft Office 2007 or greater.
  • Must be able to work extended hours when required.
  • Motivated team player, able to work with team members to meet objectives.
  • Must have an acute attention to detail, be a self-starter and be able to work with little supervision while maintaining goals/tasks.
  • Ability to work with peers with respect and professionalism.

Paramedic

Reports to: Program Manager (BA/BE)


FLSA Status: Exempt


Primary Responsibility:

Possess and apply knowledge and skills necessary to perform the duties of an Emergency Medical Technician and Emergency Medical Technician Paramedic, in a dignified and compassionate manner.


Job Duties:

  • Performing blood pressure, venipuncture, weights, pulse, respiratory rate, and temperature readings.
  • Preparing an accurate recording of ECGs, insertion of IV, and blood collection via IV catheter.
  • Collecting and processing of biological samples as specified in the protocol and ensuring the proper distribution of those samples.
  • Monitoring meals to ensure dietary compliance by research participants.
  • Assisting with screening procedures as needed.
  • Accurately recording all research data obtained or observed.
  • Handling participant complaints efficiently and effectively in order that their satisfaction is maintained.
  • Ensuring that client and participant confidentiality is maintained.
  • Responding to client and team queries in a timely manner.
  • Maintain and ordering any medication in the site’s Emergency Crash Cart.
  • Testing and maintenance of rescue and medical equipment.
  • Administering basic and advanced life support to patients at the scene if needed.
  • Able to work with and teach other personnel.
  • Able to understand and follow oral and written instructions and orders.
  • Maintain a professional attitude when representing the Phase I department.
  • Establish and maintain effective working relationships with other employees.
  • Adhere to and follow all policies and procedures concerning safety and contamination by blood borne pathogens.

Required Qualifications:

High School Diploma/GED. College degree education in specific field related to Biological Science. Licensed medical fields (EMT, Paramedic, CMA). One year full time experience directly related to the project or program. Laboratory positions require experience in a laboratory environment/or laboratory analysis. Experience in IV therapy, blood draws. Knowledge of basic office software such as Word and Excel.

Preferred Qualifications:

Bachelor's degree in a Biological Science. Excellent writing skill and the ability to work independently with attention to detail. Experience in Phase I research.

Medical Assistant

Reports to: Program Manager (BA/BE)


FLSA Status: Exempt


Primary Responsibility:

Primary Responsibility: The incumbent in this role is responsible for providing medical assistant support in various departments including clinical operations and PK lab.


Job Duties:

Participate in the selection of subjects for clinical trials and conduct procedure on study. Duties may include but are not limited to:
  • Ability to learn quickly
  • Procurement of blood samples
  • Obtaining ECGs
  • Obtaining vital signs
  • Performing a subject interview
  • Processing of blood and urine samples as per protocol requirements
  • Documenting and packaging of study samples for shipment to the appropriate clinical diagnostic laboratory or analytical laboratory
  • Obtaining subject’s height and weight
  • Performing urine and saliva screening for restricted substances
  • Study related tasks (such as meals, assembly, check-in procedures, property room, and other tasks as needed.)
  • Provide administrative support as required, including but not limited to copying, numbering, binding and archival of project and supporting documentation
  • Monitor subjects during in-house confinement periods per protocol and SOP requirement (posture, meals, activity restrictions etc.)
  • Ensure compliance with appropriate SOPs, GCP, and ICH guidelines
  • Participate in training sessions and protocol implementation
  • Work in a safe manner that does not endanger yourself or co-workers
  • Execute other duties as may be required by the Laboratory Supervisor and other members of management team as training and experience allows
  • Assist in maintainence of equipment and keep all inspection and calibrations up to date
  • Basic legal knowledge of the clinical research field
  • Ability to lift 20 lbs.
  • Teamwork skills

Qualifications:

  • Medical Assistant certified
  • 1-2 years of medical assistant experience
  • 1-2 years of experience in a basic laboratory setting
  • Very organized, detail-oriented and able to multi-task
  • Requires tact and discretion in dealing with and handling confidential information
  • Strong patient interaction skills, proven experience in dealing with patients in a calm and friendly manner
  • CPR/BLS certified
  • Clinical research experience preferred.
  • Phlebotomy training
  • Proficiency with Office software: Excel, Word, PowerPoint, Outlook.




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