Clin Research Coordinator II- Jeffersonville, Indiana

Syneos Health

247d

About The Position

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

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.
• 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.

Responsibilities

• 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 including clinic logistics planning, schedule of clinic activities, and team training.
• Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials.
• In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study.
• Confirms all required regulatory and contractual documentation is present prior to study start.
• Support the Principal Investigator as needed with study related tasks such as Delegation of Authority Log and management of daily tasks.
• 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.
• Supervise clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provide on-call support when applicable.
• Screens eligibility prior to randomization; oversees, coordinates and/or performs study drug administration, and other activities as delegated and required.
• 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.
• Prepare for and participate in sponsor/monitor/QA audits.
• 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, internal and external meetings, and other company-related initiatives and goals.
• Accommodate flexible schedule (available days, afternoons, nights, and weekends).
• Perform other work-related duties as assigned.

Benefits

• Career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to a Total Self culture.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree