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Study Coordinator Phase I

Novum is a global company with small company values like teamwork and a commitment to excellence.

At Novum, our mission is to ensure excellence where everyone works as an integral part of the team to get the job done. We provide ongoing training, mentoring, and professional development. As part of the Novum Pharmaceutical Research Services team you will work with inspiring managers and talented coworkers who are all empowered to make significant and lasting contributions to the world we live in.

Position Summary
Coordinate and oversee all aspects necessary for clinical study progression, according to the study protocol and Standard Operating Procedures (SOP’s).

Essential Responsibilities

Work with source document staff on development and QC of study specific documents.
Coordinate initiation meeting with all pertinent staff e.g., Recruiting, Screening, Source Documentation, Maintenance, Pharmacy, Quality Assurance, etc. prior to study start.
Review clinic schedule for adequate staff coverage of all protocol activities and communicate any concerns to Clinic Manager.
Consult with Pharmacy staff for drug handling, dispensing, dosing time and dosing intervals.
Meet with maintenance staff regarding clinic set-up to ensure all routine and special needs (e.g., EKG tables, extra phlebotomy stations) are accounted for.
Review sample collection and processing instructions with Phlebotomists to ensure all requirements are followed.
Work with Screening Department to ensure participants meet all eligibility criteria.
Participate in dosing of study participants.
Record any adverse events (AE) and discuss with Investigator as appropriate. For each study period prepare adverse event summary for Client Services.
Supervise (as necessary) all Research Associates, Technicians and Phlebotomists during assigned study.
Communicate all staff issues to management for appropriate follow up.
Orient and train new staff as applicable.
Conduct and coordinate check-in procedures for study.
Ensure that all other support services are accounted for (e.g., all supplies are available and meals have been ordered).
Verify documentation of all study activities.
Assign case report form completion to appropriate staff.
QC all case report forms for accuracy within specified time frame.
Compute participant payments based on completed study participation.
Follow-up on participants who have open adverse events and/or need repeat laboratory tests after study completion.
Communicate pertinent study observations or problems to the Principal Investigator and management.
Complete tables for final report.
Cross-train for other departments as needed.

Qualifications

Associate’s Degree or equivalent, or Nursing qualification, 3 years work experience in a medical or clinical research setting, prefer one year of supervisory/management experience and/or equivalent combination of education and experience.
Ability to prioritize projects and work schedules to ensure timely completion of projects.
Very high attention to detail and follow up.
Strong organizational skills.
Excellent communication skills both written and verbal.
Flexible work schedules, able to work 10-12 hour shifts, evenings and regular weekends as needed.

Requirements

Current CPR certification is required or must be obtained within 1 week of hire.

Novum provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job Type: Full-time

Benefits: