Site Director

Description

Altus Research, Inc. is an independent clinical research site that has conducted over 250 industry-sponsored trials in diverse indications and screened and consented over 20,000 patients since the program’s inception in 2006. We strive to provide innovative approaches to clinical trial management.

We currently operate in a partially integrated eSource and eRegulatory environment facilitating day to day operations and real-time information access internally and to study sponsors. Altus Research has a deep commitment to our elite team of Coordinators, Marketing and Recruitment staff and support continuing education, and ACRP Certification for clinical staff.

Benefits:

We offer you a generous compensation package including: paid time off, 401k, medical, dental vision and life insurance. A bonus package based on site performance is also included.

Summary of your Key Responsibilities:

Your primary responsibility is to oversee and manage all aspects of clinical research trials conducted at the site and ensure compliance with applicable regulations, standards, and guidelines (e.g., GCP). You will also be responsible for lead Business Development activities, Contracts & Budgets and General Site Administrative duties, and manage day-to-day operations for the site, including payroll and benefits. You will work closely with the Medical Director to assure the continued success of the site.

Duties and Responsibilities:

• Act as a supervisor and mentor to research coordinators and ancillary staff.
• Manage the workload and responsibilities of site staff. Coordinate and supervise the collection and documentation of study data and manage the research team to ensure smooth operations and timely completion of studies
• Lead Business Development activities, Contracts & Budgets and site administrative duties, and manage day-to-day operations for the site, including payroll and benefits.
• Create strategies with the Marketing & Recruitment staff to identify potential study participants. Work with the recruitment team and investigators to meet or exceed study enrollment.
• Maintain site specific SOP’s and review and update as needed
• Review the study design and inclusion/exclusion criteria
• Support subject inclusion onto clinical trials through screening, enrollment and follow up according to protocol requirements
• Supervise participant safety and assist coordinators with reporting of adverse events or deviations from protocol
• Ensure the protection of study patients by training staff in the proper informed consent procedures and adhering to protocol requirements/compliance
• Ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data
• Ensure that adequate and accurate records are maintained for Sponsor or FDA inspections
• Create study specific tools for source documentation when not provided by sponsor
• Help staff collect, complete, and enter data into study specific case report forms or electronic data capture systems. Develop workflows to generate and track drug & device shipments, and supplies as needed
• Maintain accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications
• Help staff track and report adverse events, serious adverse events, protocol waivers, deviations, and violations, and provide updates to Sponsors and IRB
• Communicate all protocol-related issues to investigators and study coordinator
• Attend study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so
• Apprise principal investigator and Monitors of all study specific medical issues for guidance
• Assist in sponsor and US FDA audit teams. Review and respond to any monitor and audit findings
• Maintain patient confidentiality according to ethical and legal requirements
• Responsible for coverage after hours and on weekends as necessary

Qualifications

· ACRP Certification

Competencies:

• Knowledge of federal regulation and good clinical practices (GCP’s)
• Knowledge of medical and research terminology
• Significant experience with human resources and personnel management
• Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel
• Excellent Verbal and written communication skills
• Excellent interpersonal skills
• The ability to communicate and work effectively with a diverse team of professionals
• Organizational and prioritizing capabilities
• The ability to work independently in a fast pace environment with minimal supervision at off-site facilities
• Knowledge of Study Contracts & Budgeting

Education:

· The position requires an RN, BS or BA degree.

· Business coursework

Experience:

Your experience should include:

• At least five years of experience as a Clinical Research Coordinator
• Some research experience in Womens health is preferred
• Supervisory experience

We look forward to speaking with you about this phenomenal opportunity. Apply to hear more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Job Type: Full-time

Pay: $80,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Office

Ability to Relocate:

• Palm Springs, FL 33461: Relocate before starting work (Required)

Work Location: In person