Director of Research Operations

Overview of the Position:

The Director of Research is responsible for the oversight, coordination, and execution of HopeHealth's clinical research program, including Phase II-IV clinical trials and grant-funded quality improvement initiatives. This position serves as the primary research operations leader and is responsible for all protocol implementation, regulatory documentation, participant management, sponsor communications, and study compliance activities.

The Director of Research ensures that all studies are conducted according to FDA regulations, ICH-GCP guidelines, sponsor requirements, IRB approvals, and organizational policies. This role functions as the lead research coordinator for the organization and maintains hands-on involvement in participant visits, informed consent, specimen collection, vital signs, source documentation, and data entry.

Qualifications (Required) Qualifications

• Master's degree in Public Health, Nursing, Clinical Research, Healthcare Administration, or related field required.
• Current BLS Certification required.
• CCRC, CCRP, or equivalent clinical research certification preferred.
• 5+ years of clinical research coordination experience.
• Experience coordinating Phase II-IV clinical trials.
• Experience with industry-sponsored and investigator-initiated studies.
• Experience with grant-funded research or quality improvement projects preferred.

Skills and Abilities

• Proficiency with clinical trial management and EDC platforms (IQVIA, SIP, Q2, Medidata, Veeva, REDCap).
• Strong understanding of FDA regulations, ICH-GCP, HIPAA, and IRB requirements
• Ability to perform phlebotomy and obtain vital signs.
• Strong organizational and documentation skills.
• Experience managing multiple concurrent studies.
• Excellent communication and relationship management abilities

Position Responsibilities

Clinical Trial Operations

• Coordinate and manage all aspects of Phase II-IV clinical trials from study startup through closeout.
• Maintain protocol compliance and ensure adherence to sponsor and regulatory requirements.
• Conduct feasibility assessments and assist with site selection activities.
• Serve as primary liaison between sponsors, CROs, investigators, monitors, and site personnel.
• Coordinate monitoring visits, audits, and sponsor inspections.

Regulatory & Documentation Management

• Maintain Investigator Site Files (ISF), regulatory binders, and essential documents.
• Prepare and submit IRB applications, amendments, continuing reviews, and reportable events.
• Ensure accurate source documentation and maintenance of study records.
• Track protocol deviations, adverse events, serious adverse events, and corrective action plans.
• Maintain study delegation logs, training records, and protocol documentation.

Participant Care & Research Procedures

• Screen, recruit, and enroll study participants.
• Conduct informed consent discussions and documentation.
• Perform vital signs, phlebotomy, specimen processing, ECGs, and protocol-specific assessments.
• Coordinate participant scheduling and follow-up visits.
• Support participant retention and engagement efforts.

Data Management & Technology

• Enter and maintain study data within sponsor and CRO electronic systems.

• Resolve data queries and ensure timely database completion.

• Utilize industry-standard clinical trial platforms including:

• IQVIA

• SIP

• Q2 Solutions

• Medidata Rave

• REDCap

• Maintain data quality and audit readiness.

Grant-Funded Quality Improvement Projects

• Coordinate implementation of externally funded quality improvement initiatives.
• Collect and analyze project metrics and outcomes.
• Prepare grant reports and documentation required by funding agencies.
• Collaborate with clinical leadership to implement evidence-based improvements.

Physical Requirements:

Must be able to lift 30 pounds. Vision and hearing corrected to within normal limits is required. Must have manual dexterity to key in data; utilize computer, grab, grip, hold, tear, cut, sort, and reach.