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Company

Original Job Post

Syneos Health · 3 days ago

Clinical Research Coordinator II

Greater Cleveland

Full-time

Onsite

Entry, Mid Level

$52/hr - $62/hr

1+ years exp

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Responsibilities

Review assigned protocols and other protocol documentation for accuracy and feasibility.

Prepare and maintain the Investigator Site File and/or Trial Master File for the study.

Coordinate all required start-up activities including clinic logistics planning and preparation of study materials.

Support the Principal Investigator with study-related tasks such as delegation of authority and visit calendar development.

Perform all study activities following Good Clinical Practices (GCP) and manage multiple clinical trials simultaneously.

Protect the safety of human subjects and collect study data into the appropriate system.

Coordinate and monitor screening activities, assist with informed consent, and submit data in the required timeframe.

Facilitate audits of study data, develop patient rapport, and respond to inquiries by auditors for data clarification.

Supervise clinic visits, oversee study drug administration, and monitor all study-related activities according to protocol and regulations.

Coordinate resolution of internal/external findings, review and oversee close-out of study documentation, and ensure completion of other close-out activities as required.

Prepare for and participate in sponsor/monitor/QA audits, provide project status updates, and collaborate within and between teams for process improvement.

Maintain proper protocol, consent, and submission requirements, report adverse events, and travel up to 100% as needed.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical researchICH GCPSOP writingCoordinating projects computer softwareProblem solvingPlanningEvaluationTime managementDetail-orientedMulti-taskingInterpersonal skillsCommunication skillsTeam focusAnticipating problemsProviding solutionsClinical Research CertificationEDC Software Proficiency

Required

Registered Nurse and/ or University Degree such as Bachelor of Science Degree required.

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).

Preferred

Clinical Research certification preferred.

Proficiency in use of various clinical trial EDC software preferred.

Company

Syneos Health

Glassdoor

3.8

Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.

Founded in 1985

Morrisville, North Carolina, USA

10,001+ employees

https://www.syneoshealth.com/

H1B Sponsorship

Syneos Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (40)

2022 (45)

2021 (88)

2020 (76)