Senior Project Manager – Clinical Trial Manager, Oncology
Syneos Health
Clinical Research Coordinator
Syneos Health
part-time
Posted on:
Location Type: Remote
Location: Remote • Texas • 🇺🇸 United States
Visit company websiteJob Level
Junior
Tech Stack
Google Cloud Platform
About the role
- Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources
- Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study
- Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings)
- Take the lead and/or overall coordination of all required start-up activities
- Support the Principal Investigator as needed with study related tasks
- Advertise, recruit, and screen potential participants for the study
- Perform all study activities following Good Clinical Practices (GCP)
- Manage multiple clinical trials simultaneously
- Protect the safety of human subjects
- Monitor appropriate sources for specific clinical study or federal regulation updates
- Collect and enter study data into the appropriate system
- Coordinate and monitor screening activities; provides support as required
- Assist with informed consent of study subjects
- Submit data in required timeframe
- Complete Case Report Forms
- Facilitate audits of study data
- Develop patient rapport to explain research protocols and minimize protocol violations
- Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings
- Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings
- Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation
- Provide accurate and timely project status updates to Project Managers and sponsor
- Collaborate within and between teams during process improvement exercises, SOP creation and/or revision
Requirements
- Registered Nurse and/ or University Degree such as Bachelor of Science Degree required
- Clinical Research certification preferred
- A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects. 2+ years preferred
- Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines
- Required skills: problem solving, planning, and evaluation
- Possess good time management, detail-oriented, and able to multi-task
- Good interpersonal and communication skills with a team focus
- Knowledge of SOP writing
- Ability to anticipate problems and provide solutions in a timely manner
- Ability to coordinate multiple clinical research projects with competing deadlines
- Proficiency in computer software programs (e.g. Word, Excel, Power Point)
- Proficiency in use of various clinical trial EDC software preferred
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchGood Clinical Practices (GCP)Case Report Forms (CRF)protocol documentationdata entryadverse event reportingSOP writingclinical trial coordinationstudy data managementregulatory compliance
Soft skills
problem solvingplanningevaluationtime managementdetail-orientedmulti-taskinginterpersonal skillscommunication skillsteam collaborationanticipation of problems
Certifications
Registered NurseBachelor of Science DegreeClinical Research certification
