Unblinded Clinical Research Coordinator I (3777)
Job Overview
Employment Type
Full-time
Compensation
Hourly
Range $22.75 - $30.00
Work Schedule
Standard Hours
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
Professional development opportunities
Flexible work schedule
Employee wellness programs
Job Description
DM Clinical Research is a specialized clinical research organization dedicated to advancing medical science through meticulously conducted clinical trials. With a focus on improving patient outcomes and supporting pharmaceutical innovation, DM Clinical Research provides comprehensive services that range from trial design to data management and regulatory compliance. The company is known for its commitment to quality, integrity, and ethical standards in the research field. Operating with experienced clinical professionals and state-of-the-art resources, DM Clinical Research plays a crucial role in the development of new treatments and therapies that meet rigorous scientific and regulatory criteria. This organization fosters a collaborative environment that encourages continuous learning and professional growth, ensuring that both staff and study participants benefit from the most current and effective research practices. The workplace culture emphasizes transparency, accountability, and teamwork, making it an attractive workplace for those passionate about clinical research and healthcare advancement.
The role of Unblinded Clinical Research Coordinator I at DM Clinical Research is a pivotal position responsible for managing the dispensing of Investigational Products (IP) within clinical trials. This role requires a detail-oriented individual who can compound and dispense IPs accurately according to Sponsor-approved protocols while maintaining strict compliance with study blinding plans and regulatory guidelines. The Unblinded Clinical Research Coordinator I will work closely with study sponsors, principal investigators, and team members to ensure smooth trial operations. This position demands strong organizational skills and the ability to handle multiple tasks in a fast-paced clinical environment. The incumbent will also perform regular audits to assess the completeness and accuracy of clinical data, maintain comprehensive medication records, and facilitate training for new team members, contributing to team development and protocol adherence.
Additionally, the coordinator is responsible for managing study IP inventory, ensuring secure storage and temperature regulation, and documenting all aspects of IP accountability, including receipt, dispensing, returns, and destruction. They will interpret clinical schedules and trial protocols to create resources that streamline IP preparation and dosing. The Unblinded Clinical Research Coordinator I also supports company start-up activities and develops operational procedures and guides to enhance workflow efficiency. This role requires excellent communication skills, as the coordinator must liaise with various stakeholders to clarify protocol requirements and ensure the highest standards of clinical trial execution. This position is ideal for professionals with clinical research experience who are passionate about contributing to the success of cutting-edge clinical trials and who thrive in a highly regulated and team-oriented environment.
The role of Unblinded Clinical Research Coordinator I at DM Clinical Research is a pivotal position responsible for managing the dispensing of Investigational Products (IP) within clinical trials. This role requires a detail-oriented individual who can compound and dispense IPs accurately according to Sponsor-approved protocols while maintaining strict compliance with study blinding plans and regulatory guidelines. The Unblinded Clinical Research Coordinator I will work closely with study sponsors, principal investigators, and team members to ensure smooth trial operations. This position demands strong organizational skills and the ability to handle multiple tasks in a fast-paced clinical environment. The incumbent will also perform regular audits to assess the completeness and accuracy of clinical data, maintain comprehensive medication records, and facilitate training for new team members, contributing to team development and protocol adherence.
Additionally, the coordinator is responsible for managing study IP inventory, ensuring secure storage and temperature regulation, and documenting all aspects of IP accountability, including receipt, dispensing, returns, and destruction. They will interpret clinical schedules and trial protocols to create resources that streamline IP preparation and dosing. The Unblinded Clinical Research Coordinator I also supports company start-up activities and develops operational procedures and guides to enhance workflow efficiency. This role requires excellent communication skills, as the coordinator must liaise with various stakeholders to clarify protocol requirements and ensure the highest standards of clinical trial execution. This position is ideal for professionals with clinical research experience who are passionate about contributing to the success of cutting-edge clinical trials and who thrive in a highly regulated and team-oriented environment.
Job Requirements
- Associates degree required or 2 years of formal educational coursework
- 2+ years of clinical research experience, inclusive of in-clinic experience, required
- 1+ year of clinical research coordinator experience, blinded or unblinded, required
- Completion of DMCR-required training, including GCP, OSHA and IATA
- Computer proficiency, especially word, excel, outlook, and google suite products
- Excellent communication and customer service skills, both written and verbal
- Excellent time-management skills
- Ability to remain composed under pressure and high-stress situations
- Well-organized with attention to detail
- Must be able to multitask
Job Qualifications
- Associates degree required or 2 years of formal educational coursework
- Bachelor's degree, preferred
- Secondary or foreign medical graduate, preferred
- 2+ years of clinical research experience, inclusive of in-clinic experience, required
- 1+ year of clinical research coordinator experience, blinded or unblinded, required
- 1+ year utilizing CRIO, preferred
- LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant), preferred
- Pharmacy technician certification, preferred
- Completion of DMCR-required training, including GCP, OSHA and IATA
- Computer proficiency, especially Word, Excel, Outlook, and Google Suite products
- Excellent communication and customer service skills, both written and verbal
- Excellent time-management skills
- Ability to remain composed under pressure and high-stress situations
- Outgoing personality
- Well-organized with attention to detail
- Must be able to multitask
- Bilingual (Spanish) preferred
Job Duties
- Compound and dispense prescribed IP as needed by sponsor approved protocol
- Study IP management
- Provide training and guidance for new team members
- Assist in all aspects of company start up activities as required
- Supervise and maintain records of all medications
- Ensure compliance with study-specific blinding plans
- Perform regular audits on the clinical data to assess percent completeness and accuracy
- Assist in onboarding training for new members
- Ensure external sites' regulatory documents and required site certifications are up to date
- Provide consultative support regarding the preparation and dosing of drugs
- Maintain documentation of IP accountability receipt, dispensing, return to sponsor/destruction
- Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials
- Understand and apply all applicable site procedures
- Ensure receipt and proper storage of IP and bioretention samples, including temperature reporting
- Develop operating procedures, guides and best practices for data entry portals and project workflows
- Interact 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 manager
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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