Clinical Research Sub-Investigator

Summary:

The Sub Investigator has responsibility for the clinical safety of the patients partaking in the clinical trial, collecting, and recording accurate clinical data while also ensuring that the well-being and interests of the subjects enrolled in the studies are being met. The Sub-I provides essential clinical support to the clinical research coordinators, principal investigators, and other clinical trials staff. Position is 25-30 hours a week.

Duties/Responsibilitie

• sServe as leader of a study team to execute clinical trial
• sMentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skill
• sCreate training strategies and mitigation plan
• sConduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia’s SOP
• sImplement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports
• .Apply project management concepts to manage risk and improve quality in the conduct of a clinical research stud
• yDevelop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols
• .Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
• .Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving querie
• sEnsure confidentiality of patient protected health information, sponsor confidential information and Eximia confidential information is maintained by all team member
• sDevelop communication and escalation strategies within teams to that ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Eximia SOP
• sEnsure all data is entered into the sponsor's data portal and all queries are resolved in a timely manne
• rEnsure staff are delegated and trained appropriately and documente
• dEnsure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements
• .Evaluate potential subjects for participation in clinical trials including phone and in person pre-screens
• .Create and execute recruitment strategies in conjunction with patient recruitment staf
• fIncorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol
• .Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol
• .Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protoco
• lDevelop Quality Control strategies for team member project
• sPerform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scop
• ePromote respect for cultural diversity and conventions with all individuals
• .Understand the disease process or condition under stud

y
Required Skills/Abilitie

• s:Must be licensed as a MD, DO NP, or PA in the state you work i
• n.Must undertake all training and certification required by sponsors and CRO’s to carry out clinical trials within specified timeline
• s.Safe handling of data and records regarding privacy and confidentiality, per HIP
• AArequirement
• s.Practices professionalism and integrity in all actions – Demonstrated ability to fost
• erconcepts of teamwork, cooperation, self- control, and flexibility to get the work do
• neAbility to communicate effectively in English (both verbal and written
• ).Up to 10% travel, as needed, for project team meetings, client presentations and oth
• erprofessional meetings/conferences as neede
• d.Other duties as assigne

d.Education and Experienc

• e:Must be a licensed MD, PO NP, or P
• A.5 years of clinical experience or equivalent applicable experience in clinical research indust