Regional Director - Clinical Research Operations

Regional Director

*Leadership Position*

Our rapidly growing clinical research company is looking to hire a qualified candidate for the full-time position of Regional Director to join our Clinical Research Operations team. The ideal candidate will possess proven leadership and mentoring experience, prior clinical research experience, and the ability to travel regularly via air and/or car between locations. The role is responsible for the developmental, operational, and performance oversight of assigned Research Centers.

The ObjectiveHealth Way

Our approach is to directly impact lives. We are identifying and caring for patients where they’re already being seen – in the physician practice. By partnering with leading physicians, we have created premier clinical trial centers that are working together to provide the necessary data aimed at developing new therapies for NASH and improving patient outcomes.

Everything we do at ObjectiveHealth is focused on helping patients. We’re offering them more regular, specialized care. We’re addressing a need. We’re making innovative, new treatment options available. We’re changing lives through an innovative approach to research and patient care. But what sets us apart isn’t our methodology, our science, or even our decades of experience in the medical field. It’s our people. People who view medicine in a new way – one that’s aimed at developing groundbreaking treatment options for patients. People who share a passion for advancing our unique brand of patient care.

We invite you to be part of the innovation we’re working toward.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Provide developmental, operational, and performance oversight for multiple (approximately 2 – 5) assigned Research Centers.
• Ensure that procedures are conducted according to clinical trial protocols; sponsor instructions; established company policies and procedures; all applicable state and federal regulations; Good Clinical Practices (GCPs); and ICH/FDA guidance documents.
• Manage new Research Center implementation, including staff hires and ancillary business development.
• Oversee resource allocation at the Research Center.
• Assume ownership of Research Center operational goals, financial performance, quality control checks, staff performance, and clinical trial enrollment goals. Responsible for tracking, monitoring, and reporting with regards to these metrics.
• Guide staff in the achievement of established Research Center goals and assist them with adaptation in the event of changing priorities.
• Communicate performance standards and expectations to Research Center staff.
• Support strategic and tactical plan for Research Center growth.
• Meet with Investigators and executive management as needed, to assess performance of the Research Center (including the identification of bottlenecks) and provide recommendations regarding specific actions and process improvements that are aimed at improving Quality and efficiency.
• Assist with training Research Center staff.
• Work with Research Center staff to address clinical, operational, and research-related issues as they arise. Handle and/or diffuse challenging situations in a professional manner.
• Ensure that study-specific processes are communicated appropriately to ensure consistent application across all participating Research Centers.
• Assist in the completion of Business Agreements, as needed.
• Organize, lead, and/or participate in any site, company, or study-team meetings, as needed.
• Liaise between investigators, ancillary partners, physicians, sponsoring organizations, and/or regulating bodies while ensuring HIPAA regulations are followed.
• Review scientific literature, participate in continuing education activities, and/or attend conferences/seminars in order to maintain and enhance industry knowledge. This may require out-of-town travel.
• Participate in both internal company audits and external sponsor audits and ensure appropriate corrective/preventive actions are implemented for any applicable audit findings.
• Mentor Research Center staff and support individual professional development.
• Lead annual performance reviews for staff.
• Additional duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to maintain professionalism and professional standards.
• Technologically advanced: Ability to learn new software systems easily.
• Must have a sense of urgency and set priorities.
• Must have the desire for regular and efficient patient interaction including in-person scheduled office visits, phone calls, and emails.
• Identify and resolve problems effectively and efficiently.
• Excellent communication and organizational skills for managing workflow and follow-up.
• Ability to demonstrate reliability and maintain confidentiality.
• Knowledge of electronic medical record systems and EDC systems.
• Knowledge of CTMS systems preferred.

EDUCATION AND EXPERIENCE:

• Bachelor's Degree or equivalent
• 2 years experience in related industry-funded clinical research
• Prior leadership experience including mentoring/coaching
• Related medical certification preferred
• Bachelor's Degree in related field preferred
• Valid U.S. Driver’s License

BENEFITS

ObjectiveHealth offers competitive compensation, 401(k), Short and Long Term Disability, Health Savings and Flexible Spending Accounts, health, dental and vision insurance, generous PTO, and several other benefits.

EEO EMPLOYER

ObjectiveHealth provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

JOB TYPE

Full-time, Exempt

LOCATION

This position is a hybrid role in that it can be performed partially remote, but does require regular on-site travel to assigned Research Centers.

Job Type: Full-time

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• Signing bonus

COVID-19 considerations:
Providing continued in-person care is necessary for the health and well-being of our patients. To further protect employees during this time, we have implemented COVID-19 specific policies and PPE procedures based on current CDC recommendations.

Application Question(s):

• How many Clinical Trials have you worked on previously?

Experience:

• Industry-funded Clinical Trials: 2 years (Preferred)
• Team management: 1 year (Preferred)

Willingness to travel:

• 75% (Preferred)

Work Location: Remote