Lead Clinical Research Coordinator

• Must live in/around Mishawaka, IN as this position is on-site.

PURPOSE AND SCOPE: Assists with clinical trial activity, site profit and loss, subject enrollment strategy, and staffing, potentially at multiple clinical research site locations. Ensures research studies are conducted according to the protocol and established company policies and procedures as well as all applicable State and Federal regulations under supervision of the Principal Investigator (PI) and direct supervisor. Responsible for performance of study-specific procedures, collection of patient safety data, investigational product management, accurate data collection, data entry, and other duties as delegated and supervised by the PI and governed by Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.


PRINCIPAL DUTIES AND RESPONSIBILITIES:
General Administration
· Assists with clinical research staff including but not limited to: interviewing and hiring new staff, training of new and existing staff, staff coverage, and team meetings
· Trains to review or negotiate clinical trial contracts, confidentiality disclosure agreements and other legal documents as needed
· Maintains a state of site level audit-readiness
· Trains to Interpret and recommend changes to operational policies as needed, and establish procedures that positively affect provided services
· Interacts in a positive and productive manner with internal and external customers, particularly in problem resolution
· Supports clinical research staff as needed to ensure research subject safety and quality of data
· Trains to ensure oversight of clinical research staff accurate utilization of the Clinical Trials Management System
· Participates and presents at meetings with internal and external representatives as needed, often leading a cooperative effort among members of a project team
· Collaborates to implement processes and operational policies in selecting methods and techniques for obtaining solutions
· Assists local site manager with quality assurance program following the Working Practice Guideline; may be delegated to train local staff and oversee quality assurance program guidelines.
· Assists SMO managerial team in ensuring execution and implementation on quality, education and training across the SMO sites, assisting with quality oversight of SMO locations as requested.
· Serves as a resource for clinical research staff by maintaining up to date knowledge of medical terminology, clinical research trends, Good Clinical Practice, and other site-specific regulations
· Provides resource planning for physician office and dialysis facility-related research
· Liaises with sponsors, CROs, physician practice members and Frenova Renal Research staff
· Acts as an adviser to subordinate(s) to meet schedules and/or resolve technical problems
· Trains to provide leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters
· Represent organization at industry events, mastery of presentation and writing skills
Conduct of Research
• Trains as a protocol expert to aid sites with protocol questions and concerns as needed
• Attends investigators meetings and industry conferences as necessary
• Ensures clinical trial research regulatory approvals are obtained and maintained
• Ensures clinical research staff understand clinical trial objectives, timelines, and tasks
• Ensures clinical trial enrollment goals are met according to project timelines
• Ensures training is up to date for all staff-research or facility support-as required per study protocols.
• Assists with ensuring clinical research, physician office and dialysis facility staff are prepared for on-site visits by CRO, sponsor or regulatory parties
Financial Management
· Assists with site expenses
· Trains to review study budget and line-item payments against predicted accrual
· Trains to develop or negotiate clinical trial site budgets
· Performs other duties as assigned

PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• This job operates in an office setting. While performing the duties of this job, the employee is regularly required to talk and hear. This role routinely and frequently uses a desk and standard office equipment such as computers, phones, and photocopiers with repetitive motion.
• Physical effort required. Employee must be able to lift and carry up to 30 pounds.
• This position does involve direct contact with patients and includes performing phlebotomy procedures, as needed. Occupational Health and Safety Risks include potential exposure to blood borne and airborne pathogens.
• Occasional travel between assigned offices/facilities and various locations within the community and investigator meetings, physician offices and regional and corporate meetings, up to 25% of the time required.

SUPERVISION:
· Responsible for the direct supervision of various levels of clinical research staff, potentially in multiple locations

EDUCATION AND REQUIRED CREDENTIALS:
• Bachelor’s Degree or an equivalent combination of education and experience

EXPERIENCE AND SKILLS:
· Minimum of 5+ years of clinic research experience; or equivalent CRC I/II experience.
· Leads specific studies and exposure to supervisory experience by supervising staff with respect to specific study related tasks.
· Clinical Research Coordinator certification (e.g., CCRC or CCRP) highly preferred.
· Current state licensure, if applicable
· Training/experience in management or other leadership roles is desirable
· Experience using a Clinical Trials Management System preferred
· Excellent interpersonal, verbal and written communication skills, attention to detail, organizational and prioritizing skills, and time management skills required
· Demonstrates excellence in leadership, autonomy, flexibility, self-direction, integrity, team building and mentoring capabilities
· Demonstrated knowledge of Good Clinical Practice and ICH, as well as OSHA standards and other site-specific regulations
· Excellent interpersonal, verbal and written communication skills, attention to detail, organizational and prioritizing skills, and time management skills required.
· Ability to work independently, and exhibit diplomacy and problem-solving skills in the performance of this role
· Proficient in the use of electronic systems and the Microsoft Office suite of products

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

EOE, disability/veterans