Clinical Research Coordinator

October 19

🤠 Texas – Remote

Although this job is listed in Texas, this company may be open to hiring remote in other states.

⏱ Part Time

🟢 Junior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Syneos Health

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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