Clinical Research Coordinator (level dependent on experience)

Socket.dev; Cincinnati (OH); Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work from home opportunities

Health benefits

Vacation packages

Paid parental leave

Job summary

Socket.dev is seeking a Clinical Research Coordinator to oversee Phase I–IV studies in compliance with GCPs, ICH guidelines and SOPs, from pre-study planning through completion of visits.

You will maintain protocol knowledge, recruit volunteers, prepare source templates, ensure safety and regulatory compliance, coordinate visits, and interact with investigators and sponsors to support accurate medical evaluation and data integrity.

Qualifications

• 1+ year of experience as a clinical research coordinator or in a similar position within the medical or mental health field
• Bachelor’s degree in life sciences or equivalent combination of related experience and education in the medical or mental health field
• Clinical Research Coordinator Certification (CCRC) is preferred
• Associate or Bachelor’s Degree in Nursing is preferred
• Advanced Cardiac Life Support (ACLS) is preferred

Responsibilities

• Maintain a good level of knowledge and understanding of assigned protocols, including all protocol requirements for study visits, obtaining informed consent, study visit schedules, tests, procedures, laboratory information, and drug accountability requirements
• Recruit subject volunteers for studies; Work with the Recruitment Department with developing study-related materials and interview questionnaires
• Create source templates for study documentation, complete case report forms, and other study specific documents seeking assistance from Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, Team Leader or Clinical Site Director, as needed
• Ensure consistency and effective communication during study visits and assure all procedures are conducted in compliance with the clinical protocol; Maintain subject safety, assess feedback from study participant and refer to investigators or other professionals as needed; If applicable, administer study medications based on state licensure, account for medications used
• Coordinate and conduct study visits; Assure all procedures are conducted in compliance with the clinical protocol and in accordance with all applicable regulations and in compliance with GCPs
• Interact with Investigators or study sponsors as needed to assure the study participant receives appropriate medical evaluation and care when needed
• Interact with the sponsor Clinical Research Associate to facilitate the sponsor monitoring and database clean-up process
• Attend sponsor Investigator/Study Coordinator meetings as needed for assigned protocols
• Conduct clinical research in compliance with all applicable regulations; Request assistance and technical advice from Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, Team Leader, or Clinical Site Director, as needed
• Actively seeks out development opportunities
• Behave cooperatively and constructively; Follow all company policies, state, local, federal, and other applicable laws and guidelines; Comply with all job-specific requirements

Education

Bachelor’s degree in life sciences

Associate or Bachelor’s Degree in Nursing

Clinical Research Coordinator Certification (CCRC)

Advanced Cardiac Life Support (ACLS)

Job description

Coordinate the conduct ofPhase I through Phase IVclinicalresearch studiesin accordance withGood Clinical Practices(GCPs), International Harmonization Guideline and Standard Operating Procedures(SOPs) beginning withpre-study planning through successful completion of all study visits.

What You'll Do:

• Maintaina good levelofknowledge and understanding of assigned protocols, including all protocol requirements forstudyvisits, obtaining informed consent,studyvisit schedules, tests, procedures, laboratory information, and drug accountability requirements
• Recruitsubject volunteersfor studies;Work with theRecruitment Department withdeveloping study-relatedmaterialsand interview questionnaires
• Create source templates for study documentation, complete case report forms, andother study specific documents seekingassistancefrom Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, TeamLeaderor Clinical Site Director, as needed
• Ensure consistency and effective communication duringstudyvisits and assure all procedures are conducted in compliance with the clinical protocol; Maintainsubjectsafety, assessfeedback fromstudy participantand refer to investigators or other professionals as needed;If applicable,administer study medications based on state licensure, account for medications used
• Coordinate and conductstudyvisits; Assure all procedures are conducted in compliance with the clinical protocol andin accordancewithall applicable regulations and in compliance with GCPs
• Interact with Investigators or study sponsors as needed to assure the study participantreceivesappropriate medicalevaluation and care when needed
• Interact with the sponsor Clinical Research Associate tofacilitate the sponsor monitoring and database clean-up process
• Attend sponsor Investigator/Study Coordinator meetings asneeded for assigned protocols
• Conduct clinical research in compliance with all applicable regulations; Request assistance and technical advice from Senior Clinical Research Coordinator, Principal Clinical Research Coordinator, TeamLeader, or Clinical Site Director,as needed
• Actively seeksout development opportunities
• Behave cooperatively and constructively; Follow all company policies, state, local,federal, and other applicable lawsand guidelines;Comply with alljob-specific requirements

What You’ll Bring:

• 1+ year of experience as a clinical research coordinator or in a similar position within the medical or mental health field
• Bachelor’sdegree in life sciences or equivalent combination of related experience and education in the medical or mental health field
• Clinical Research Coordinator Certification (CCRC) ispreferred
• Associate orBachelor’s Degree in Nursing is preferred
• Advanced Cardiac Life Support (ACLS) ispreferred

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Equal Opportunity Employer/Veterans/Disabled