Sr. Study Coordinator

United-Biosource-Corporation; United States; Remote; USD 65,000 - 90,000; Full time

Benefits offered by this job

Remote opportunities

Growth opportunities for promotion

401K with company match*

Flexible work environment

Discretionary PTO (Paid Time Off)

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Job summary

United-Biosource-Corporation (UBC) is seeking a licensed Practical Nurse with at least 2 years of study coordination experience for a 6-month fixed-term remote role from the UBC Study Coordinating Center. You will support clinical research activities, ensure GCP compliance, and manage data and communications across investigators, sponsor, and team.

Work remotely from the US, with potential extension, and mentorship to junior coordinators.

Qualifications

• Licensed Practical Nurse in state of practice
• Minimum 2 years of study coordinator experience
• Strong understanding of GCP and research ethics
• Proficient in Microsoft Office Suite and EMR systems
• Ability to work independently and as part of a team
• Willingness to work flexible on-call shifts
• Ability to multitask and prioritize tasks

Responsibilities

• Support screening process including informed consent and medical records
• Schedule and conduct telehealth visits and study procedures
• Collect and maintain accurate clinical data per GCP
• Coordinate end-to-end patient journey including home visits and site visits
• Prepare reports for PI, Sub-I, and Sponsor
• Mentor junior study coordinators
• Monitor protocol adherence and address deviations
• Ensure regulatory documentation is complete and up-to-date
• Handle inbound/outbound study communications
• Report adverse events as appropriate

Education

Licensed Practical Nurse (LPN) license

Study coordinator experience

GCP knowledge

EMR systems proficiency

Time management

Communication

Teamwork

On-call flexibility

Multitasking

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

US-Fixed Term Research & Clinical Remote, US

4 days ago Requisition ID: 7604

As a pharmaceutical support industry leader, UBC is devoted to empowering health solutions for a better tomorrow. We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

This is initially a 6 month Fixed Term Contract with the possibility of extending longer term

Responsible for supporting the conduct of clinical research from the setting of the UBC Study Coordinating Center (home based), ensuring the safety and well-being of participants while working closely with investigators, the sponsor and the research team to manage all aspects of the study, adhering to strict protocols and regulations.

Specific job duties:

• Supporting the screening process for potential participants including obtaining informed consent and acquiring medical records
• Schedule and conduct patient telehealth visits, performing study procedures as delegated by the PI and outlined in the protocol
• Collect, record, and maintain accurate clinical data in compliance with Good Clinical Practice (GCP) guidelines
• Manage investigational drugs logistics, from shipping through proper storage, accountability, and administration
• Coordinate the ‘end to end’ journey for the patient’s participation in the study including home health nursing visits, telehealth visits with the PI/Sub-I, visits to brick and mortar sites, shipment of study supplies and collection of samples, and use of technologies (ePRO/eCOA/devices).
• Prepare accurate and timely reports for the PI, Sub-I and Sponsor
• Training and mentorship for junior level study coordinators
• Monitor the study for adherence to the protocol and identify and address any deviations
• Maintain regulatory compliance by ensuring all required documentation is completed and up-to-date
• Handle inbound and outbound contacts from various sources (patients, healthcare providers, client, etc.) related to a specific UBC study
• Maintain a working knowledge of study guidelines, medication, or disease being referenced in call scripts, frequently asked questions, project specific procedures and study reference material
• Conduct communication through various channels (phone, fax, email) to retrieve data or to address discrepancies in data received
• Complete full follow-up with regards to missing information from stakeholders, including data entry process, as applicable, documentation, and safety reporting per study guidelines
• Ensure data entry, filing, and data confirmation are completed accurately and in a timely manner
• Apply corrections and/or updates to the secured study applications and/or appropriate documents that have been identified through data verification or follow up calls
• Document all communications in the appropriate application contact log in an accurate, concise, and timely manner
• Responsible for reporting any adverse events as appropriate
• Escalate potential problems or issues that require management’s immediate attention
• Responsible for ensuring all study compliance duties (including re-education of stakeholders, documentation of non-compliant event, review of alerts/ reminders, and healthcare provider follow-up) are completed
• Preparation of study reporting materials for client meetings
• Other duties as assigned by the Project Manager, Coordinating Center Manager, Coordinating Center Director, and as determined by UBC SOPs

Supervisory Responsibility:

• Study specific oversight of smaller teams of junior level study coordinators (if applicable)

Desired Skills and Qualifications:

• Licensed Practical Nurse or equivalent license in the state of practice
• Minimum 2 years of study coordinator experience
• Strong understanding of GCP and research ethics
• Excellent organizational, time management, project management and communication skills
• Proficient in Microsoft Office Suite and electronic medical record (EMR) systems
• Ability to work independently and as part of a team
• Compassionate and empathetic demeanor for interacting with patients
• Ability to work flexible work schedule that could include 24/7 on call coverage shifts
• Ability to work on complex programs or multiple programs at the same time requiring critical thought processing
• Proficient in multitasking and ability to prioritize tasks

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

• Remote opportunities
• Growth opportunities for promotion
• 401K with company match*
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.