Clinical Research Director

Role

The Clinical Research Director (CRD) is a specialized research professional working with and under the direction of the Principal Investigator (PI) as well as the CEO and president of the company. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRD supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRD works with the PI, research team, and sponsor to support the administration of the compliance, financial, personnel and other related aspects of the clinical study. In addition, the CRD will assist in managing the day-to-day operations of the office as well as provide leadership and support to the staff.

Responsibilities

• The CRD's primary responsibility, as with all clinical research staff, is to ensure the protection and well-being of the subjects participating in the study. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRD supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRD works with the PI and sponsor to support and provide guidance on the administration of the compliance, financial, personnel, and other related aspects of the clinical study.
• Ensures adherence to standard operating procedures, Good Clinical Practice and FDA regulations.
• Assists the PI with study start up including IRB submission of requested regulatory documents, ensuring staff study protocol training, managing the delegation logs, communicating with Sponsor, and assisting with budget and CTA as requested by the PI and CEO.
• Oversees and maintains study regulatory documents.
• Coordinates with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with federal regulations, site-specific policies and procedures, and sponsor required policies and procedures.
• Maintains effective and ongoing communication with the sponsor, research participants, appropriate Company staff and PI during the course of the study.
• Works with the PI to manage the day-to-day activities of the study, including problem-solving, communication, and protocol management.
• Reviews and comprehends the protocol, investigator brochures (when applicable), and all study-related manuals/guidelines and assists study staff in the understanding of these items.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Prepares and/or oversees the creation of study-related documentation, including but not limited to source documents, adverse event reports, and progress notes.
• Oversees the establishment and organization of study files, including but not limited to study-specific source documentation and other materials.
• Attends investigator meetings as required or requested by the PI.
• Provides availability as requested by management for after-hours urgent calls from study subjects to ensure subject safety.
• Assists PI in communicating study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members—documents date of training and signatures of study personnel trained on the study-specific training log.
• Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
• Conducts or participates in the informed consent process, including interactions and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Conducts procedural aspects of studies, including standards of care, informed consent procedures, or documentation procedures.
• Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
• Coordinates participant tests and procedures.
• Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Oversees the maintenance of an adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Clinical Trials Center of Middle Tennessee, LLC SOP on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures, including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Maintains all study records, including but not limited to case report forms, drug dispensation records, or regulatory forms in accordance with sponsor requirements and Clinical Trials Center of Middle Tennessee, LLC policies and procedures.
• Coordinates appropriate and timely payments to participants (if applicable) in accordance with Clinical Trials Center of Middle Tennessee, LLC policies and procedures.
• Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem-solving efforts such as protocol revisions.
• Coordinates and facilitates monitoring and auditing visits.
• Collaborates with PI and Institution to respond to audit findings and implements approved recommendations.
• Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Assists the CEO with Human Resource responsibilities including interviewing, onboarding, and training of new employees, as well as providing ongoing oversight and support.
• Ensures study personnel including Investigators are up to date with appropriate GCP, HSR and other necessary training and certifications.
• Creates as necessary and updates study staff CVs in the company standard format.
• Assists in employee evaluations as requested by the CEO.
• Reports to the CEO and assists in addressing any employee issues of conduct or performance below the standards of the company or in violation of the Employee Handbook or Company policies and procedures.
• Assists with purchasing office supplies and assists with record keeping of such expenses