Position:

Principal Investigator (Neurology)

About the job:

Tekton Research is looking for a Principal Investigator (Neurology) to join our team in Austin, TX!

The Principal Investigator (PI) will lead the execution of clinical trials in Alzheimer’s Disease at Tekton’s assigned Neurology research sites. The PI will oversee all aspects of clinical trial conduct in compliance with ICH/GCP guidelines and FDA regulations, ensuring the safety of participants, integrity of data collected, and compliance with study protocols. The ideal candidate is a Board-Certified Neurologist with significant experience as a PI in Alzheimer’s Disease trials.

As a PI, you will collaborate with Tekton’s operational teams, clinical coordinators, and external sponsors to execute high-quality clinical trials. This position requires clinical oversight of trial protocols, patient management, and timely reporting to sponsors and regulatory agencies.

Job Description:

• Provides clinical oversight for all Alzheimer’s Disease trials at Tekton’s Neurology sites.
• Acts as the Principal Investigator for clinical trials, ensuring compliance with protocols, ethical standards, and regulatory requirements (FDA, GCP).
• Reviews and approves study protocols, informed consent forms, and other relevant documents.
• Works with feasibility team to determine the enrollment potential for the site according to the protocol specifications.
• Engages and recruits eligible participants, ensuring patient safety and proper monitoring throughout the trial.
• Reviews patient medical history and performs assessments necessary for inclusion in clinical trials. • Collaborates with site staff, clinical research coordinators, and monitors to ensure timely and accurate data collection.
• Interfaces with sponsors, CROs, and Tekton’s operations team to ensure alignment on study objectives and timelines.

Required Skills/Abilities:

• Board certification in Neurology, with a subspecialty focus on Alzheimer’s Disease preferred.
• Active Medical License in assigned state with no open or past action items.
• 5+ years of experience as a Principal Investigator in clinical trials, with at least 3 years in Alzheimer’s Disease trials.
• Deep knowledge of clinical research processes, FDA regulations, ICH/GCP guidelines, and relevant ethical standards.
• Proven ability to engage with patients and clinical staff to maintain a high standard of care in a research setting.
• Strong organizational skills with a demonstrated ability to manage multiple projects simultaneously.
• Excellent written and oral communication skills for reporting and interaction with sponsors and clinical staff.
• Experience in patient recruitment and retention in clinical trials.
• Familiarity with electronic data capture systems and clinical trial management software.
• Ability to work in a fast paced environment and collaborate with site staff.

Education and Experience:

• M.D. or D.O. degree with board certification in Neurology.
• Extensive clinical and research experience in Alzheimer’s Disease.
• Prior experience as a PI in Alzheimer’s Disease clinical trials.

The Research Assistant supports the research team in the daily operations of clinical trials. It is the responsibility of the Research Assistant to communicate with the study team, site manager, and study participants regarding necessary information about the study. Adherence is required to all Tekton SOPs.

Reports to:

Site Manager/Director

Job Description:

• Support the recruitment efforts through pre-screening and scheduling patients
• Prepare source binders for patient visits
• Medical record requests
• Ensure e-diaries are scheduled and completed by the subject
• Check patients in/out
• Ensure patients are paid
• Answer and transfer phone calls
• Inventory lab and study supplies, assist in lab tasks as required
• Record adverse event data and confer with investigators regarding the reporting of events to sponsors
• Study data management: Enter data in the EDC within 24 hours of visit completion and resolve queries within 24 hours of the query being issued.
• Maintain accurate master logs for each study. (ie, ICF, patient ID, and screening/enrollment logs)
• Assist in maintaining study documentation and filing systems.
• Blood/sample collection, processing, shipping, and documentation as required
• Vital Sign collection and documentation (including EKGs)
• Other duties as assigned

Required Skills/Abilities:

• 6+ months Medical Assistant/EMT or other medical experience preferred
• Ability to work independently and as a member of a team
• Research experience is a plus

Education and Experience:

• GED or HS Diploma required (Some College preferred)

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds
• May require occasional travel to clinical sites.

A CRC-I is part of a collaborative site team. Projects will include training on the responsibilities of clinical trials, while also being responsible for the daily operations and overall management of assigned clinical trials as deemed appropriate by site management based on training and experience. It is the responsibility of the CRC I to communicate with site staff, management, and study participants. Adherence to Tekton SOPs is required.

Reports to:

Site Manager

Job Description:

• Enrollment of clinical trials according to protocols.
• Inform patients or caregivers about studies and associated procedures.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
• Know the contents of and maintain assigned study e-regulatory binders
• Follow all Tekton work instructions, guidelines, policies, and controlled documents.
• Scheduling of study visits and monitoring schedules according to protocol and study plan. Prepare study participants source documents prior to study participants visit.
• Maintain assigned study training logs/Delegation logs as required.
• Maintain all safety reports for all studies. Confirm PI is aware of safety reports to be reviewed and that reports are signed as required by investigators.
• Have all source documentation completed while the patient visit is occurring and while the patient is on site for optimal accuracy and completeness of data collection.
• Data collection: all source documentation completed, entered into EDC within 48 hours of patient visit. Apply relevant good documentation practices.
• Inventory lab and study supplies. Notify site management when supplies need to be ordered.
• Maintenance of required records of study activity including case report forms, drug dispensation records
• Perform specific protocol procedures and interpret complex medical data (ie: interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens).
• Record adverse event data and confer with investigators regarding the reporting of events.
• Resolve data queries in the EDC within 24 hours of query being issued.
• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as required.
• Identify, report, and problem solve protocol deviations or unanticipated events.
• Drug Accountability. Logging investigational product shipments and reporting received as required. Thorough documentation if lost or damaged. Logging dispensed medication to subjects in appropriate medication log as required per study protocol.
• Initiate and maintain accurate master logs for each study. (ie: ICF, patient ID, and enrollment logs).
• Participate in quality assurance audits as required, as well as study SIVs as required.
• Label and organize space for investigational products. All IP received should be stored with restricted access immediately once the IP arrives at the site.
• Maintain confidentiality of patient protected health information and sponsor confidential information.
• Other duties as assigned

Required Skills/Abilities:

• 6 months – 2 years clinical research experience preferred
• Ability to work independently and as a member of a team
• GED or HS Diploma required (Some College preferred)
• Effective verbal and written communication skills
• Ability to read, write, and speak English language
• Potential for travel to assist & train at Tekton Research sites
• Knowledge of basic medical terminology

Education and Experience:

• College or medical certification required
• Phlebotomy if required by state law

Physical Requirements:

• Must be able to lift up to 15 pounds
• Prolonged periods of sitting at a desk and working on a computer

Responsible for the daily operations and overall management of assigned clinical trials including administrative duties and regulatory functions. Responsible for clear and direct communication with study sponsor, study monitor, CRO, PI and site management. Adherence to Tekton SOPs is required. The CRC II works collaboratively with the CRC I to train and guide them on Tekton SOPs, protocol, and regulatory compliance. It is the responsibility of the CRC II to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner.

Reports to:

Site Manager

Job Description:

• Enrollment of clinical trials according to protocols, identifying ways to exceed enrollment goals.
• Confer with the recruitment department and site management to determine the best recruitment practices for assigned studies.
• Inform patients or caregivers about studies and associated procedures
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
• Know the contents of and maintain assigned study e-regulatory binders, self-check all binders for compliance and forward any missing documentation to binders regularly.
• Follow all Tekton work instructions, guidelines, policies, and controlled documents, assist CRC-Is as needed by providing guidance on following and applying these documents.
• Scheduling of study visits and monitoring schedules according to protocol and study plan
• Have all source documentation completed while the patient visit is occurring and while the patient is on site for optimal accuracy and completeness of data collection. Apply relevant good documentation practices.
• Data collection: all source documentation completed and entered into EDC within one business day of patient visit. Ensure data queries are resolved in the EDC within 48 hours of query being issued
• Inventory lab and study supplies. For assigned studies maintain an acceptable threshold of supplies required to complete study visits and meet site enrollment goals.
• Attend investigator meetings with principle investigator: asks questions and collect pertinent study information while at any investigator meeting
• Attend site initiation visits from various drug sponsors and conduct site initiation tours
• Maintenance of required records of study activity including case report forms, drug dispensation records
• Perform specific protocol procedures and interpret complex medical data (ie: interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens) as required.
• Communicate with laboratories or investigators regarding laboratory findings.
• Record adverse event data and confer with investigators regarding the reporting of events
• Manage study data entry, ensuring timelines are met for entry of all source data into study systems/EDC
• Direct the requisition, collection, labeling, storage, or shipment of specimens
• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as required
• Identify, report, and problem solve protocol deviations or unanticipated events.
• Drug Accountability. Logging investigational product shipments and reporting received as required. Thorough documentation if lost or damaged. Logging dispensed medication to subjects in appropriate medication log as required per study protocol.
• Initiate and maintain accurate master logs for each study. (ie: ICF, patient ID, and enrollment logs).
• Participate in quality assurance audits as required
• Ensure IP management for assigned trials: Space for investigational products is labelled and organized and required. All IP is stored with restricted access immediately once the IP arrives at the site and checked in by delegated staff.
• Maintain assigned study training logs/Delegation logs as required.
• Maintain all safety reports for all studies. Confirm PI is aware of safety reports to be reviewed and that reports are signed as required by investigators.
• Maintain confidentiality of patient protected health information and sponsor confidential information.
• Other duties as assigned

Required Skills/Abilities:

• Experience leading multiple clinical trials as lead CRC preferred
• Ability to work independently and as a member of a team
•  Ability to train and guide staff effectively and knowledgeably
•  Effective verbal and written communication skills
•  Ability to read, write, and speak English language
•  Knowledge of high-level medical terminology
•  Potential for travel to assist & train at Tekton Research sites

Education and Experience:

• GED or HS Diploma required (Some College preferred)
• 2 – 5 years clinical research experience required
• Phlebotomy if required by state law

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds at times

CRC-III is the most senior clinical research coordinator at Tekton Research. They are responsible for the overall management of a high volume of studies including administrative duties and regulatory functions. The CRC III is responsible for clear and direct communication with study sponsor, study monitor, CRO, PI and site manager. Adherence to Tekton SOPs is required. The CRC-III mentors and trains both CRC-I and CRC-II roles and is a resource for high level problem solving and planning of clinical trials. The CRC-III should require minimal direct oversight, fully owning all assigned clinical trials from startup to closeout and meeting enrollment goals. It is the responsibility of the CRC III to represent himself/herself and the site in the most professional, ethical and positive manner.

Reports to:

Site Manager

Job Description:

•  Meet enrollment of clinical trials according to protocols, identifying ways to exceed enrollment goals.
• Confer with the recruitment department and site management to determine the best recruitment practices for assigned studies.
• Inform study participants or caregivers about study procedures.
• Train study team members and monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
• Have all source documentation completed while the patient visit is occurring and while the patient is on site for optimal accuracy and completeness of data collection. Apply relevant good documentation practices.
• Data collection: all source documentation completed and entered into EDC within one business day of patient visit. Ensure data queries are resolved in the EDC within 48 hours of query being issued
• Know the contents of and maintain assigned study e-regulatory binders, self-check all binders for compliance and forward any missing documentation to binders regularly.
• Follow all Tekton work instructions, guidelines, policies, and controlled documents, assist CRC-Is as needed by providing guidance on following and applying these documents.
• Scheduling of study visits and monitoring schedules according to protocol and study plan
• Prepare study participants source documents prior to patient visit
• Inventory lab and study supplies. For assigned studies maintain an acceptable threshold of supplies required to complete study visits and meet site enrollment goals.
• Attend investigator meetings with principle investigator asks questions and collect pertinent study information while at any investigator meeting
• Attend site initiation visits from various drug sponsors and conduct site initiation tours
• Ensure maintenance of required records of study activity including case report forms, drug dispensation records
• Delegate and perform specific protocol procedures and interpret complex medical data (ie: interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens) as required.
• Communicate with laboratories or investigators regarding laboratory findings.
• Record and review adverse event data captured, confer with investigators regarding the reporting of events
• Manage study data entry, ensuring timelines are met for entry of all source data into study systems/EDC
• Direct the requisition, collection, labeling, storage, or shipment of specimens
• Oversee the dispensation of medical devices or drugs, calculation of dosages, drug compliance and provide instructions as required to meet study protocol requirements
• Identify, report, and problem solve protocol deviations or unanticipated events.
• Drug Accountability. Logging investigational product shipments and reporting received as required. Thorough documentation if lost or damaged. Logging dispensed medication to subjects in appropriate medication log as required per study protocol.
• Ensure maintenance of accurate master logs for each study. (ie: ICF, patient ID, and enrollment logs).
• Participate and prepare in advance for any quality assurance audits as required
• Ensure IP management for assigned trials: Space for investigational products is labelled and organized and required. All IP is stored with restricted access immediately once the IP arrives at the site and checked in by delegated staff.
• Maintain assigned study training logs/Delegation logs as required.
• Ensure maintenance of all safety reports for all studies and that study PI is aware of safety reports to be reviewed and that reports are signed as required by investigators.
• Function as a subject matter expert in the area of Clinical Research to provide support and guidance for peers
• Maintain confidentiality of patient protected health information and sponsor confidential information.
• Other duties as assigned

Required Skills/Abilities:

• Experience leading a high volume of clinical trials as lead CRC required
• Ability to work independently and as a member of a team
• Ability to train and guide staff effectively and knowledgeably
• Effective verbal and written communication skills
• Ability to read, write, and speak English language
• Knowledge of high-level medical terminology
• Ability to travel to assist & train at Tekton Research sites

Education and Experience:

• GED or HS Diploma required (Some College preferred)
• 5+ years clinical research experience required
• Phlebotomy if required by state law

Physical Requirements:

• Must be able to work remotely and be available during business hours
• Must be able to lift up to 15 pounds at times

Tekton is seeking a Clinical Research Nurse Practitioner to join our team onsite in San Antonio, TX!

The Clinical Research Coordinator (CRC) / Nurse Practitioner manages the daily operations of clinical trials while serving as a Sub Investigator on clinical trials and performing medical assessments. Other responsibilities include but are not limited to: train and manage study-related staff, oversee preparation for study conduct and ensure necessary approvals and documentation are in place, communicate with sponsors, investigators, and participants, perform study-related procedures such as informed consent and data collection, perform phlebotomy and lab duties, manage study supplies, laboratory procedures, and closeout activities.

Essential Qualifications:

• 2+ years Clinical Research experience
• Nurse Practitioner Licensure – TX
• Bilingual
• Experience with phlebotomy and laboratory procedures
• Ability to make sound medical judgments in relation to clinical research protocols
• Proficiency in performing medical procedures and assessments
• Self-motivated, team player with strong attention to detail & ability to multitask
• Strong verbal and written communication skills
• Ability to travel up to 15% between San Antonio site locations

Tekton Research is a growth-oriented research company focused on excellent conduct of clinical trials. We are team-oriented and core value-centric. We value Focus, Discipline, and Accountability. We offer benefits and a competitive salary.

At Tekton Research, we do excellent work and are Making Life Better.