The Director of Regulatory Compliance oversees the compliance and regulatory aspects of all clinical trials, ensuring that research activities adhere to local, federal and international regulations. Responsible for managing the submissions of documents to regulatory agencies, monitoring the regulatory progress of all clinical studies, and any compliance issues that should arise.

Job Description:

• Review, manage and assess the electronic regulatory system in collaboration with vendor engineering to meet the needs of company expansion and growth.
• Provide guidance, support, interpretation and training to clinical operations for adherence and compliance to regulatory agency guidelines and requirements.
• Create, maintain and enforce regulatory department procedures to ensure consistent workflow across clinical operations and in support of audit readiness
• Collaborate with Corporate Operations in onboarding new employees, investigators, and associated regulatory and clinical operations
• Liaise with Recruitment, and Finance in assuring regulatory adherence and oversight of marketing materials and participant stipends in support of clinical trial activation
• Lead and/or participate in the assessment, development, and implementation of critical projects in support of regulatory management directed toward continuous quality improvement
• Implement, manage, and supervise the Biosafety process for clinical operations and ensure regulatory registration and compliance is established and maintained
• Develop and provide regular reporting to Leadership on Regulatory metrics
• Assess Regulatory growth and development needs based on company goals
• Manage Regulatory staff in accordance with company policies (plan, assign, and direct work, perform evaluations and guide professional development)
• Creation of company policies, forms, and work instructions as related to regulatory procedures, participate in development and annual review of company SOPs
• Maintain current industry trends, standards, and policies. (FDA, GCP, IRB, EU, etc.)

Essential Qualifications:

• 5-7 years Regulatory Compliance experience in pharmaceuticals, CRO, and/or site network
• 3-5 years of Management experience
• Demonstrate knowledge of industry regulatory procedures in compliance with regulatory agency requirements and regulatory affairs
• Strong leadership and management skills to assess regulatory risks and support quality improvement
• Possess strong work ethic and integrity in interpreting and implementing regulatory strategies
• Broad knowledge of FDA, IRB, and ICH GCP agency policies and guidelines
• Bachelor and/or Master’s degree in a scientific or healthcare-related field

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.

Tekton Research is the leading U.S. clinical trial site network bringing Phase I-IV pharmaceutical and medical device clinical trials into physician offices. Through this embedded partnership model with practicing physicians who serve as its Principal Investigators (PIs), Tekton provides its biopharma and CRO clients with world-class access to diverse patient populations. By leveraging that doctor-patient relationship, Tekton prides itself on its ability to identify, enroll and retain the right patients for the right studies. Tekton has 25 sites across seven states today and is seeking an exceptional individual to lead our continued network expansion in certain Therapeutic Areas (TAs).

The Director of Principal Investigator Partnerships will report directly to the CEO and hold primary responsibility for leading Tekton’s nationwide site network expansion. This executive will identify (via their existing and ever-growing contact list) high potential physician groups; introduce them to Tekton’s unique physician-PI value proposition; and vet their experience, capabilities and dedication to running clinical research – ultimately converting and bringing these physician-PIs into the Tekton family. This high-energy, entrepreneurial leader will work collaboratively with Tekton’s Therapeutic Area leaders, Business Development team, and Operational organization to maintain alignment on strategy, targeted geographies, and TAs/indications of focus. Success at Tekton is driven by cross-functional execution. The market opportunity for expansion is immediate, and preference will be given to individuals with actionable ideas and experience building trusted relationships with doctors interested in industry-sponsored research.

Tekton Research is backed by Havencrest Capital Management, a middle-market private equity fund, building companies that are changing the way healthcare is delivered in America.

Job Description:

● Sources actionable new physician practice / site partnership opportunities.

● Manages new site partnerships from initial contact to signed contract; supporting relationship transfer to TA leads upon contract execution.

● Works in collaboration with TA leaders to effectively and efficiently meet TA-specific site expansion goals.

● Provides weekly and on-demand updates to leadership team related to new opportunities.

● Attends industry conferences, focusing on events heavily attended by research-interested physicians.

● Develops, improves and maintains slide decks/presentations/collateral for presentation to prospective PIs, especially around Tekton’s focus TAs, capabilities and value proposition.

● Maintains current knowledge of the clinical research trial process and requirements.

● Tracks all progress, vetting practices, and KPIs (e.g. targeted therapeutic areas; patient access) for

prospective PIs and site expansion opportunities in Tekton’s CRM. Tracks all engagement (recurring

meetings, escalations) related to site expansion.

● Cultivates and supports long-term relationships with PIs after contracting/site start-up.

Essential Qualifications:

● 5+ years of experience in industry-sponsored clinical research and/or physician practice management

● 3+ years in physician practice operations or selling of value-added services or revenue opportunities to physicians

● Preference for individuals with direct experience leading or selling clinical research operations inside physician practices, and/or establishing de novo research sites

● Exceptional engagement aptitude and ability with physicians, practice managers and clinical staff

● Demonstrated experience in delivering high ROI results

● Outstanding written and oral communication skills

● Salesforce or related software experience

● Bachelor’s degree or higher

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.

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

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 subject
• Check patients in/out
• Ensure patients are paid
• Answer and transfer phone calls
• Inventory lab and study supplies
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to sponsors
• Resolve all auto queries and enter data in the EDC within 24 hours of query being issued by sponsor
• Maintain accurate master logs for each study. (ICF, patient ID, and enrollment)
• Maintain accurate temperature logs daily as needed
• Blood draw and processing as needed
• EKGs
• Vitals
• 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

The Clinical Research Coordinator (CRC I) supports the daily operations of assigned clinical trials. It is the responsibility of the CRC I to communicate with CRC II or CRC III, site manager and study participants regarding necessary information of the study. Adherence to site SOPs is required.

Job Description:

• Inform patients or caregivers about study procedures and outcomes to be expected
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
• Have all source documentation filled out and completed while the patient visit is occurring and while the patient is on site for optimal accuracy of data collection
• Have all source documentation completed, entered into EDC within 48 hours of patient visit
• Inventory lab and study supplies. Notify manager when supplies need to be ordered
• Maintain required records of study activity including case report forms, drug dispensation records
• Perform specific protocol procedures such as interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to sponsors
• Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor
• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as necessary
• Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost or damaged. Logging dispensed medication to subjects in appropriate medication log
• Initiate and maintain accurate master logs for each study. (ICF, patient ID, and enrollment).
• Participate in quality assurance audits
• Label and organize space for drug. All drug received should be put in drug cabinets immediately once drug arrives to site after being checked in and logged into the drug logs
• Maintain accurate temperature logs daily as needed
• 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)
• Ability to work independently and as a member of a team

Education and Experience:

• College or medical certification required

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 overall management of the studies assigned to your administrative duties (regulatory functions). Responsible for clear and direct communication with study sponsor, study monitor and CRO, PI and site manager. Adherence to site SOPs is required.

Job Description:

The Clinical Research Coordinator (CRC II) manages the daily operations of assigned clinical trials. It is the responsibility of the CRC II to communicate with the investigator, sponsor and study participants all necessary information of the study. 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.

• Inform study participants or caregivers about study procedures and outcomes to be expected
• 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 filled out and completed while the study participants visit is occurring and while the study participant is on site for optimal accuracy of data collection
• Have all source documentation completed, entered into EDC within 48 hours of study participants visit
• Inventory lab and study supplies. Order supplies or delegate to Research Assistant to order needed supplies
• Attend investigator meetings with principle investigator: asks questions and collects pertinent study information while at investigator meeting
• Attend site initiation visits from various drug sponsors and conduct site initiation tours
• Confer with business/recruitment department to determine the best recruitment practices for studies
• Maintain required records of study activity including case report forms, drug dispensation records
• Communicate with laboratories or investigators regarding laboratory findings
• Order drugs or devices necessary for study completion
• Direct the requisition, collection, labeling, storage, or shipment of specimens
• Perform specific protocol procedures such as interviewing study participants, taking vital signs, performing electrocardiograms and taking laboratory specimens
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to sponsors
• Maintain contact with sponsors to schedule and coordinate site visits/monitoring visits
• Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor
• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as necessary
• Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost or damaged. Logging dispensed medication to study participants in appropriate medication log
• Initiate and maintain accurate master logs for each study. (ICF, study participants ID, and enrollment)
• Prepare for or participate in quality assurance audits
• Label and organize space for drug. All drug received should be put in drug cabinets immediately once drug arrives to site after being checked in and logged into the drug log
• Maintain accurate temperature logs daily as needed
• Prepare study participants source documents prior to study participants visit
• Maintain training logs on all up-to-date studies
• Maintain and update study delegation logs
• Maintains all safety reports for all studies. Make sure that PI is aware of safety reports to be completed and signs off in a timely manner
• Other duties as assigned

Required Skills/Abilities:

• Experience leading 3-5 studies preferred
• Ability to work independently and as a member of a team

Education and Experience:

• GED or HS Diploma required (Some College preferred)
• 2 – 5 years clinical research experience required

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

Responsible for the overall management the studies assigned to you including administrative duties, such as regulatory functions. Responsible for clear and direct communication with study sponsor, study monitor and CRO, PI and site manager. Adherence to site SOPs is required.

Job Description:

The Clinical Research Coordinator (CRC III) manages the daily operations of assigned clinical trials. It is the responsibility of the CRC III to communicate with the investigator, sponsor and study participants all necessary information of the study. It is the responsibility of the CRC III to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner.

• Inform study participants or caregivers about study procedures and outcomes to be expected
• 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 filled out and completed while the study participants visit is occurring and while the study participant is on site for optimal accuracy of data collection
• Have all source documentation completed, entered into EDC within 48 hours of study participants visit
• Inventory lab and study supplies. Order supplies or delegate to Research Assistant to order needed supplies
• Attend investigator meetings with principle investigator: asks questions and collects pertinent study information while at investigator meeting
• Attend site initiation visits from various drug sponsors and conduct site initiation tours
• Confer with business/recruitment department to determine the best recruitment practices for studies
• Maintain required records of study activity including case report forms, drug dispensation records
• Communicate with laboratories or investigators regarding laboratory findings
• Order drugs or devices necessary for study completion
• Direct the requisition, collection, labeling, storage, or shipment of specimens
• Perform specific protocol procedures such as interviewing study participants, taking vital signs, performing electrocardiograms and taking laboratory specimens
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to sponsors
• Maintain contact with sponsors to schedule and coordinate site visits/monitoring visits
• Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor
• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as necessary
• Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost or damaged. Logging dispensed medication to study participants in appropriate medication log
• Initiate and maintain accurate master logs for each study. (ICF, patient ID, and enrollment)
• Prepare for or participate in quality assurance audits
• Label and organize space for drug. All drug received should be put in drug cabinets immediately once drug arrives to site after being checked in and logged into the drug logs
• Maintain accurate temperature logs daily as needed
• Prepare study participants source documents prior to patient visit
• Maintain training logs on all up-to-date studies
• Maintain and update study delegation logs
• Maintains all safety reports for all studies. Make sure that PI is aware of safety reports to be completed and signs off in a timely manner
• Functions as a subject matter expert in the area of Clinical Research to provide support and guidance for peers
• Other duties as assigned

Required Skills/Abilities:

• Experience leading 6-8 studies preferred
• Ability to work independently and as a member of a team

Education and Experience:

• GED or HS Diploma required (Some College preferred)
• 5+ years clinical research experience required

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 Research is looking for a Site Manager to join our team in San Antonio, TX!

This is a fully on-site position located at 11212 State Hwy 151 Suite 180, San Antonio, TX 78251

The Site Manager is responsible for effectively managing day-to-day site activities for optimization of site performance. The Site Manager is responsible for driving the site to achieve company goals. Our clients are two-fold, the sponsor and the participant. The Site Manager is responsible for ensuring contractual obligations are met and work is completed in a manner that leads to client satisfaction. The Site Manager is also responsible for leading Endocrinology trial studies.

Essential Qualifications:

• Minimum 3-5+ years Clinical Research Site Network Management and CRC experience
• Endocrinology experience, preferred
• Excellent Leadership skills with proven management/supervisor experience
• Experience with regulatory processes, clinical procedures, sponsor interaction, and human resources preferred
• Ability to travel between site locations listed above
• College or Specialized Degree preferred

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.