Clinical Research Sub-Investigator

Description:

SUMMARY:

The Clinical Sub-Investigator (Sub-I) plays a vital role in the successful execution of clinical trials by ensuring the safety, rights, and well-being of study participants while maintaining strict adherence to study protocols, Good Clinical Practice (GCP), and regulatory standards. Working closely with the Principal Investigator (PI), the Sub-I is responsible for collecting and recording accurate clinical data, performing delegated medical procedures, and overseeing study drug administration. This role involves applying clinical expertise to evaluate participants, assess safety data, and support the integrity of participant-generated data. The Sub-I also collaborate with research coordinators, PIs, and other clinical staff to ensure regulatory compliance and high-quality patient care, contributing to the advancement of new therapies and medical innovations.

Requirements:

ESSENTIAL DUTIES:

• Support the Principal Investigator in oversight and the conduct of clinical trials and performs study activities as delegated by the Principal Investigator
• Ensure the safety and welfare of study participants
• Screen and evaluate potential study participants for eligibility based on protocol criteria
• Obtain informed consent from eligible participants, counseling and educating participants on study participation and medical procedures
• Perform delegated Sub-I duties including medical assessments, physical examinations, and other clinical procedures as required by the study protocol, such as phlebotomy, ECGs, and lab work evaluation
• Accurately collect, record, and maintain clinical trial data, adhering to regulatory and quality standards
• Monitor and report any adverse events or side effects experienced by study participants. Perform clinical-related procedures and/or make important trial-related decisions as delegated by the Principal Investigator
• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points, key timelines and endpoints, required vendors, and patient population when planning for each assigned protocol
• Ensure strict adherence to Good Clinical Practice (GCP), ICH Guidelines, local regulations, and ethical standards throughout the study. Manage the activities and performance of the clinical site staff
• Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries
• Collaborate closely with the Principal Investigator, study coordinators, and other team members to coordinate and manage the study activities.
• Create and execute recruitment strategies in conjunction with patient recruitment staff
• Possess a thorough understanding of the disease process or condition under study and the requirements of each study protocol and implement all study procedures as outlined
• Create, maintain, and organize study documentation, including study files, source documents, case report forms, and guidance documents. Ensure all essential documents, including Investigator Site File (ISF) are accurate and up to date
• Provide clear and timely communication with study participants, sponsors, and regulatory authorities as required
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements
• Stay updated on relevant clinical research developments and participate in continuing education opportunities to enhance your clinical knowledge and skills
• Complete all training and certification required by sponsors and CRO’s to carry out clinical trials within specified timelines
• Support study feasibility reviews and protocol feedback
• Participate in recruitment, monitoring visits, and audits
• Attend investigator meetings, trainings, and site visits
• Build relationships with local physicians and promote study awareness
• Mentor and support site staff, modeling best practices and professionalism
• Other duties as assigned

SUPERVISORY RESPONSIBILITIES:

• None

QUALIFICATIONS:

• Strong interpersonal and communication skills, both written and verbal
• Clear and concise written and verbal communication skills, including the ability to present ideas and suggestions clearly and effectively
• Attention to detail, the ability to work independently, and as part of a team
• Enjoy balancing hands-on patient care with research oversight
• Communicate clearly and confidently with patients and team members
• Strong scientific, analytical, and problem-solving skills
• Expertise regarding applicable compliance requirements including the ability to maintain quality, safety, and/or infection control standards
• Demonstrated ability to work collaboratively with cross functional departments/groups and various levels of employees to identify quality solutions and effectively achieve business results
• Demonstrate management skills to coordinate complex protocols with overlapping timelines
• Strong organization/prioritization skills, detail-oriented, and adaptable in a fast-paced environment
• Proven ability to lead cross-functional teams and manage complex clinical programs
• Exceptional ability to develop and maintain strong professional relationships with sponsors, key opinion leaders, and internal stakeholders
• Knowledge of related accreditation and certification requirements, including ongoing engagement in maintenance of certification for primary board certification
• Ability to travel for clinic activities, and attend investigator meetings or vendor visits/audits, as required
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and with clinical trial master filing systems and eSource

EDUCATION AND EXPERIENCE:

• Licensed PA (Physician Assistant) or NP (Nurse Practitioner) with relevant clinical research experience in good standing
• Active Board Certification is required
• Active PA or RN license in Texas and National NP Certification in good standing
• Minimum five (5) years of experience as a NP or PA in a U.S. community practice setting
• 2+ years of clinical research experience or equivalent applicable experience in clinical research industry
• Strong understanding of GCP and ICH guidelines
• CPR/ACLS certification
• Proficient in medical record-keeping and data management