Remote Clinical Country Coordinator, Home Health Clinical Trials

Marken is a wholly owned subsidiary of the UPS Healthcare division. With Polar Speed and Marken included, the UPS Healthcare division staffs 128 locations with 5500 employees worldwide. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 56 locations worldwide, while maintaining the leading position for Direct to Patient and Home Health care services, biological sample shipments and biological kit production. Marken’s dedicated 1600 staff members manage 100,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries. Additional services such as ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.

Main Purpose:

The Country Coordinator will provide country level support to Home Health Care (HHC) teams on assigned Home Health Clinical Trials. The Country Coordinator will also work closely with the Home Care and Project Management teams to assist in the planning, execution, monitoring and control of HHC studies by identifying, training and managing country level home health care agencies and providers.

These positions are remote based and can be located throughout the United States.

Primary Duties:

• This highly people oriented role and entails dealing directly with home health care organizations, home health care agencies (HCA) and home health care providers (HHCP), study sites as well as internal stakeholders involved in the conduct of a trial within Global Patient Centric Services; including Direct to Patient logistics, Kit Production, and Depot team members.
• The Country Coordinator will provide the necessary country level support to the Home Health Care team. This role will identify, qualify, onboard, and train home care agencies and providers and home care visit execution activities.
• Other responsibilities include managing/updating vendors and nurse network database, coordinating with country specific logistics.
• Project related duties for assigned projects include:

• Responsible for agency and provider identification and qualification
• Training of Home Health Care Providers (HHCP) on Marken training curriculum, home care scope of services, and home health care technology: Marken Apollo
• Collection of required home care provider documents (i.e., cv, licensure, medical license, etc)
• Assist with document collection at the site level – including the PI approvals of HHCPs (Delegation of Authority log)
• Support coordination of visit logistics with HHCP and Patient and track to completion
• Submission of home health care visit documentation to the study site within 24 hours of visit
• Create HHCP profiles in Marken’s proprietary software system Marken Apollo and update as needed
• Assigned HHCP to study specifics in Apollo

Required Qualifications:

• 2+ years of clinical research or equivalent health care experience
• 2+ years of experience in a clinical trials environment
• Bachelor’s degree in scientific discipline or equivalent experience
• Basic working knowledge of regulatory requirements and drug development process
• Comprehensive knowledge of local and global Clinical Trials Regulations
• Extended knowledge about home health care services, global project management, Applicable CFR, GCP and ICH guidelines
• Registered Nurse (RN) or LPN/LVN, phlebotomist, advanced nursing degree, i.e., Nurse Practitioner, or other equivalent medical professional
• Strong project management and organizational skills

Desired Qualifications:

• Home Health Care or virtual trial experience highly desired
• Advanced professional degree (i.e., nursing, pharmacy, etc)
• Operational experience in Home health care within the clinical research industry
• Pharmaceutical or CRO experience within related functions (i.e., clinical operations, project management, patient recruitment, medical and safety teams)

EEO & VETERAN Employer

No Agency Referrals Allowed

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• Day shift
• Monday to Friday
• Weekends

Supplemental Pay:

• Bonus pay

Education:

• Bachelor’s (Preferred)

Experience:

• Clinical research: 2 years (Required)
• Clinical trials: 2 years (Required)
• professional medical: 1 year (Preferred)

Language:

• Spanish (Preferred)

License/Certification:

• Registered Nurse (RN) (Preferred)
• ACRP, SoCRA or other GCP Clinical Research certification (Preferred)

This Job Is Ideal for Someone Who Is:

• People-oriented — enjoys interacting with people and working on group projects
• Adaptable/flexible — enjoys doing work that requires frequent shifts in direction

This Company Describes Its Culture as:

• Detail-oriented — quality and precision-focused
• Outcome-oriented — results-focused with strong performance culture

Company’s website:

• marken.com

Company’s Facebook page:

• facebook.com/Marken.LLP

COVID-19 Precaution(s):

• Remote interview process
• Social distancing guidelines in place
• Virtual meetings