Columbia, Missouri – PRN Registered Nurse

Reports to: Manager, Clinical Operations

Position Summary:

To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s, and regulatory requirements while fulfilling the business needs of the company.

Duties and Responsibilities:

  • Perform ECG, Vital Signs, obtain blood sample and study specific testing
  • Obtain Medical History and Informed Consent from potential trial subjects
  • Explanation of the use of study drug(s)
  • Dispense and Administer study drug(s),
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event Reporting
  • IV Catheter insertion and removal
  • Monitor, assess, and document assessment of peripheral IV insertion and phlebotomy sites
  • Perform drug/cotinine screen and alcohol test
  • Serve and/or monitor meals
  • Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI).
  • Monitor and maintenance of Crash Cart
  • Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
  • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
  • Maintain accurate, complete, legible and timely data entry
  • Perform any other duties as required by Supervisor

Qualifications:

  • Registered Nurse with current registration with regulatory body in Missouri or a current NLC/eNLC multistate license
  • Working experience in Clinical Research setting preferred
  • Working knowledge of Good Clinical Practice preferred
  • Current BLS and ACLS certifications
  • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.

Work Hours:

  • Ability to accommodate a flexible work schedule – on an “as-needed basis”.
  • No guaranteed minimum hours

Please send your resume to resumes@biopharmaservices.com

Columbia, Missouri – Nurse Practitioner – Clinical Research

Status:  Permanent Part-Time

Location: Columbia, Missouri

Reports to:  Principal Investigator

Position Summary:  Nurse practitioner to support Principal Investigator for clinical research studies.  Apply medical techniques and principles under the direction of a physician for the successful execution of clinical research studies.

Responsibilities:

  • Knowledge of protocol and visit requirements for assigned studies.
  • Ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
  • Maintain security and confidentiality.
  • Notify Principal Investigator of patient non-compliance or other drug-related problems.
  • Read laboratory values and report abnormal values to investigator and patient.
  • Experience applying the following regulations and guidelines: GCP, HIPPA, The Protection of Human Research Subjects, OSHA
  • Maintain certification in CPR/ACLS
  • Ensure the safety and well-being of all study subjects throughout the study.
  • Regulatory document review;
  • Verification and review and reporting of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;

Qualifications:

  • Master’s Degree in Nursing and graduation from a Nurse Practitioner Program;
  • Strong communication skills both written and verbal;
  • Ability to build strong rapport with medical site staff;
  • Excellent communicative and social skills, accuracy, perseverance and organizational skills;

Please send your resume to resumes@biopharmaservices.com

Toronto, Ontario – Associate Director, Clinical Operations

Reports to:      VP Clinical Operations

 Position summary:

Reporting to the VP Clinical Operations the Associate Director, Clinical Operations is responsible for the execution of all aspects of clinical trials.  Associate Director, Clinical Operations will be responsible for the:

  • Operational aspects of clinical studies for the Canadian Facility.
  • Management of the operational expenses for the Canadian Facility.
  • Meet expectations of corporate goals, timelines, cost and quality performance.
  • The Associate Director will oversee the planning, development, implementation, execution, and management of assigned clinical trials, as well as participate in other areas requiring scientific/technical expertise.

Duties and responsibilities:

  • Management responsibilities for the Associate Director of Clinical Operations for the Canadian facility
  • Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations
  • Directs and supervises all Clinical Leads and assigned staff members
  • Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic
  • Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results. Ensures that high-quality customer service is offered by all clinic employees
  • Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff
  • Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical studies
  • Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements
  • Interacts with Study Monitors, investigators, regulators, vendors, and others external to the Company
  • Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
  • Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings
  • Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies
  • Performs other tasks and projects as assigned

Qualifications:

  • Nine or more years’ experience in clinical trials, five years in a management role and at least 4 years of relevant experience in a Clinical Research Organization
  • Significant experience managing Phase I-IIB, Bioavailability and Bioequivalence studies
  • Degree in Health Sciences or related discipline (MD or RN preferred)
  • CCRP certification
  • Computer literacy and excellent communication skills

 

Please send your resume to  resumes@biopharmaservices.com