Unblinded Clinical Research Coordinator I

Dm Clinical Research Group; Philadelphia (Philadelphia County); On-site; USD 55,000 - 75,000; Full time

Job summary

DM Clinical Research seeks an Unblinded Clinical Research Coordinator I in Philadelphia to dispense Investigational Products and manage IPs across trials. You will train new team members, assist startup activities, and ensure IP storage and regulatory compliance.

Strong data accuracy, protocol understanding, and team collaboration are essential. The role requires CRC experience, CRIO usage, and relevant clinical research credentials.

Qualifications

• Associates Degree required or 2 years of formal educational coursework.
• Bachelor's degree preferred.
• 2+ years of Clinical Research experience, inclusive of in-clinic experience.
• 1+ year of Clinical Research Coordinator experience, Blinded or Unblinded.
• 1+ year utilizing CRIO.
• Credentials including LPN, CMA, Pharmacy Technician Certification preferred.

Responsibilities

• Dispense Investigational Products (IP) as per sponsor-approved protocol.
• Manage study IP and maintain IP accountability records.
• Provide training and guidance for new team members.
• Support startup activities and onboarding for new staff.
• Ensure regulatory documents and site certifications are up to date.
• Maintain documentation for IP receipt, dispensing, and destruction.
• Interpret schedules to plan IP compounding and dispensing.
• Apply site procedures and blinding plans.
• Ensure IP storage, including temperature reporting, is correct.
• Develop SOPs and guides for data entry portals and workflows.
• Collaborate with PI, sponsor, study manager, and other coordinators.
• Conduct audits to assess data completeness and accuracy.

Skills

Clinical research experience

CRC experience (1+)

CRIO experience

Communication skills

Time management

Multitasking

Bilingual Spanish

Education

Associates degree

Bachelor's degree (preferred)

LPN

CMA

Pharmacy Technician Certification

Foreign or Secondary Medical Graduate (preferred)

Tools

CRIO

Microsoft Word

Excel

Outlook

Google Suite

Job description

DM Clinical Research is looking to hire an Unblinded Clinical Research Coordinator I to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials.Duties & Responsibilities:Compound and dispense prescribed IP as needed by Sponsor approved protocolStudy IP managementProvide training and guidance for new team membersAssist in all aspects of company start up activities as requiredSupervise and maintain records of all medicationsEnsure compliance with study-specific blinding plansPerform regular audits on the clinical data to assess percent completeness and accuracyAssist in onboarding training for new membersEnsure external sites’ regulatory documents and required site certifications are up to dateProvide consultative support regarding the preparation and dosing of drugsMaintain documentation of IP accountability: receipt, dispensing, return to sponsor/destructionInterpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trialsUnderstand and apply all applicable site proceduresEnsure receipt and proper storage of IP and bioretention samples, including temperature reportingDevelop operating procedures, guides and best practices for data entry portals and project workflowsInteract with Principal Investigator, sponsor, study manager and other study coordinators to ensure all aspects of protocols and study requirements are understood.Any other duties or tasks assigned by the managerKNOWLEDGE & EXPERIENCEEducation:Associates Degree required or 2 years of formal educational courseworkBachelor's degree, preferredSecondary or Foreign Medical Graduate, preferredExperience:2+ years of Clinical Research experience, inclusive of in-clinic experience, required1+ year of Clinical Research Coordinator experience, Blinded or Unblinded, required1+ year utilizing CRIO, preferredCredentials:LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant), preferredPharmacy Technician Certification, preferredCompletion of DMCR-required training, including GCP, OSHA and IATAKnowledge and Skills:Computer proficiency, especially Word, Excel, Outlook, and Google Suite products.Excellent communication and customer service skills, both written and verbalExcellent time-management skillsAbility to remain composed under pressure and high-stress situationsOutgoing personalityWell-organized with attention to detail.Must be able to multitask.Bilingual (Spanish) preferred