Responsibilities/ Job Duties:

• Serve as leader of a study team to execute clinical trials
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
• Create training strategies and mitigation plans
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members
• Develop communication and escalation strategies within teams to that ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and SOPs
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Ensure staff are delegated and trained appropriately and documented
• Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
• Create and execute recruitment strategies in conjunction with patient recruitment staff
• Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
• Incorporate understanding of how decisions affect the bottom-line including links between operations and company's financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.
• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
• Develop Quality Control strategies for team member projects
• Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
• Promote respect for cultural diversity and conventions with all individuals.
• Understand the disease process or condition under study
• Other duties as assigned

Minimum Education and Experience Qualification Requirements:

Required Skills/Abilities:

• Must be licensed as a MD, DO, NP, or PA in the state you work in.
• Must undertake all training and certification required by sponsors and CRO's to carry out clinical trials within specified timelines.
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements.
• Practices professionalism and integrity in all actions - Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
• Ability to communicate effectively in English (both verbal and written).
• Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
• Other duties as assigned.

Education and Experience:

• Must be a licensed MD, DO, NP, or PA.
• 5+ years of clinical management experience or equivalent applicable experience in clinical research industry preferred

Schedule/ Shift: 40 hours a week, M-F 8-5

Benefits:

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances)

• Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).)

• 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1)

• Short Term Disability Insurance

• Term Life Insurance Plan

Medix is acting as an Employment Agency in relation to this vacancy.