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Open Positions
Overview
The Headlands Research - AMCR Institute is dedicated to attracting, nurturing, and retaining patients and staff in order to carry out outstanding metabolic research. Our volunteers, sponsors, partners, and staff enjoy working together in an environment of mutual respect that fosters personal growth and optimal health. We passionately believe that the participation of a few in clinical research studies can make a difference to the many that suffer from chronic metabolic conditions. We strive to be the best at what we do and at all times be meticulous in all our practices placing the care, safety, and confidentiality of our volunteers first. Excellence in clinical research, accelerating access to treatments that change lives.
Together with Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, Headlands Research is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.
The Role
AMCR is looking for a Clinical Research Coordinator to coordinate and plan research study-related activities. This person will be responsible for ensuring day-to-day adherence to protocol, regulatory standards, and established policies and practices to deliver high quality and timely study data.
Position Type: Full-Time
Pay Range: $25-$29/hr
Location: Escondido, CA
Travel: 0%
Work Schedule: Mondays through Fridays, 8:00am to 8:00pm
Responsibilities
- Coordinates all study-related tasks from start to finish for:
- Low to medium complexity/demand: 2 enrolling studies and 2 ongoing studies
- High complexity/demand: 1 enrolling study and 2 ongoing study
- Or reasonable combination of the above
- Reviews and comprehends the protocol
- Documents and maintains required training for all key personnel involved in the delegated clinical trial
- Establishes and organizes study files, including but not limited to, regulatory binders, CRF’s, study specific source documentation to ensure all data are correctly captured and attributable.
- Coordinates and facilitates monitoring visits
- Maintains detailed study records per FDA guidelines
- Maintains adequate inventory of study supplies
- Informs study participants of study objectives
- Monitors research participants to ensure adherence to study requirements
- Maintains effective ongoing communication with sponsor, research participants and PI during the study
- Works with the Investigator to manage the day-to-day activities of the study including problem solving, communication and protocol adherence
- Maintains good relationships with co-workers, Sponsors, CRO’s, third party vendors and other organizations through excellent communication skills and customer service skills.
- Attends staff, department and sponsor meetings as required
- Identifies and communicated important protocol and data management concerns to supervisor in a timely manner
Qualifications
- Bachelor's Degree preferred
- Minimum one year experience as a Clinical Research Coordinator required
- Nursing license, medical assistant certificate, or similar certification is preferred
- Excellent communication, interpersonal, and leadership skills, including problem solving, team building and coaching.
- Demonstrated project management skills required
- Experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations.
- Ability to work independently and prioritize actively
- Advanced computer skills, including Microsoft Office suite (including MS Project, Excel, and PowerPoint) required
- Clinical trial management system (CTMS) experience preferred, specifically Crio.
Overview
The Headlands Research - AMCR Institute is dedicated to attracting, nurturing, and retaining patients and staff in order to carry out outstanding metabolic research. Our volunteers, sponsors, partners, and staff enjoy working together in an environment of mutual respect that fosters personal growth and optimal health. We passionately believe that the participation of a few in clinical research studies can make a difference to the many that suffer from chronic metabolic conditions. We strive to be the best at what we do and at all times be meticulous in all our practices placing the care, safety, and confidentiality of our volunteers first. Excellence in clinical research, accelerating access to treatments that change lives.
Together with Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, Headlands Research is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.
The Role
AMCR is looking for a Research Assistant to organize the collection of data, documentation, and record-keeping activities pertaining to clinical research studies. This person will promote Good Clinical Practices in the conduct of clinical investigations by possessing an in-depth knowledge of FDA regulations and human subject protection, thus, ensuring compliance with protocol and regulatory requirements.
Position Type: Full-Time
Pay Range: $18-$20/hr
Location: Escondido, CA
Travel: 0%
Work Schedule: Mondays through Fridays, 7:00am to 4:00pm
Responsibilities
- Becomes familiar with study protocols
- Assists with all study-related tasks from start to finish for:
- Low to medium complexity/demand: 1 enrolling study and 2 ongoing studies
- High complexity/demand: 1 enrolling study and 1 ongoing study
- Or reasonable combination of the above
- Collects, processes, and assists in the compilation and verification of research data, sample, and/or specimens, following strict protocol and detailed instructions.
- Performs delegated duties vital signs, study questionnaires, ECG’s
- Prepares source documents and study binder for subject visits
- Schedules/confirms subject appointments
- Files in regulatory binder
- Completes data entry, CRF’s, electronic data
- Addresses electronic data capture (EDC) queries under guidance of the study coordinator
- Has working knowledge of laboratory equipment including centrifuges, scales, hematocrits, A1c, and YSIs
- Performs laboratory equipment maintenance
- Collects and processes blood samples and other biological samples
- Coordinates shipment of biological samples
- Monitors temperature monitoring system for temperature acceptability ranges
- Weekly temperature report printing and filing
- Attends study teleconferences and/or meetings
Qualifications
- Medical Assistant certification preferred
- BLS or CPR required
- Excellent communication, interpersonal skills, including problem solving
- Basic computer skills, including Microsoft Office suite (including MS Project, Excel, and PowerPoint)
Overview
The Headlands Research - AMCR Institute is dedicated to attracting, nurturing, and retaining patients and staff in order to carry out outstanding metabolic research. Our volunteers, sponsors, partners, and staff enjoy working together in an environment of mutual respect that fosters personal growth and optimal health. We passionately believe that the participation of a few in clinical research studies can make a difference to the many that suffer from chronic metabolic conditions. We strive to be the best at what we do and at all times be meticulous in all our practices placing the care, safety, and confidentiality of our volunteers first. Excellence in clinical research, accelerating access to treatments that change lives.
Together with Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, Headlands Research is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.
The Role
AMCR is looking for a Clinical Research Licensed Vocational Nurse to be responsible and accountable for the direct care of a group of research subjects during a designated time frame. The Clinical Research LVN is a licensed clinical professional working with and under the direction of the Principal Investigator, Assistant Director, Lead Research Nurse, and in close conjunction with the Clinical Project Manager on early or late phases of clinical trials related to the treatment of diabetes. The Clinical Research Nurse is an integral member of the clinical trial team and assumes responsibility and accountability for the direct research care of a group of research subjects during a designated time frame. Nursing practice is focused on subject’s safety, IV placement and management, data collection, research subject’s satisfaction, and teamwork.
Position Type: PRN/Per Diem (Shift may range from 4 to 12 hours)
Pay Range: $32-$45/hr
Location: Escondido, CA
Travel: 0%
Work Schedule: Mondays through Fridays, 8:00am to 8:00pm (Shift may range from 4 to 12 hours)
Responsibilities
- Research / Regulatory:
- Contributes to data collection by adhering to “Good Documentation Practices”
- Documents in detail the data obtained following AMCR Institute’s Standard Operating Procedure (SOP).
- Competently recognizes signs and symptoms of Hypoglycemia, Hyperglycemia, and Ketosis and alerts the lead coordinator and clinician.
- Working knowledge of research protocol to understand the science behind the study.
- Assists research staff in specimen processing: spinning, pipetting, and analyzing using the YSI glucose instrument.
- Discharge research subject upon completion of in-clinic visit following the “Glycemic Discharge Protocol for AMCR Institute”.
- Clinical:
- Conducts a centered research subject assessment focusing on safety and venous access placement.
- Using aseptic technique, identifies the largest accessible vein and starts intravenous placement (IV) on adults and pediatric research subjects. Number of IV lines depending on the research design. May place two (2) IV lines on the same arm and/or another line on the opposite arm. “Please refer to attached Venous Access Protocol”.
- Using aseptic technique, changes IV bags PRN and adjust infusion pumps flow rate.
- Employs strategies in maintaining subject’s safety: monitoring heating pad temperature, awareness of blood glucose levels, phlebitis.
- Administers research drugs and/or medications as ordered by a clinician.
- Using aseptic technique, assists research staff in blood drawing using a 3-way stopcock method.
- Assists research staff with performing vital signs and EKG tracings.
- Provides the tools and necessary support to subjects in learning their diabetes management responsibilities in accordance with the protocol.
- Provides nursing support to staff regarding diabetes issues as needed.
- Organizes and prioritizes workload to effectively accomplish goals.
- Communication
- Communicates clearly and effectively with clinicians, nursing and research staff, and research subjects.
- Check-in and report with the Lead Research Coordinator and/or RN at the start and end of each shift and provide a complete outgoing report.
- Sign / initial / and date all documents that were worked on during shift prior to leaving.
Qualifications
- Must have current and unencumbered LVN license in the state of California
- CPR certification required (ACLS preferred)
- 3+ years clinical experience as an LVN strongly preferred (less may be considered depending on clinical rotations or type of experience)
- IV skills and phlebotomy experience required
- Experience in frequent, timed, venous sampling preferred
- Experience with diabetes-related medical devices a plus
- Experience in diabetes management and/or clinical trials a plus
Overview
The Headlands Research - AMCR Institute is dedicated to attracting, nurturing, and retaining patients and staff in order to carry out outstanding metabolic research. Our volunteers, sponsors, partners, and staff enjoy working together in an environment of mutual respect that fosters personal growth and optimal health. We passionately believe that the participation of a few in clinical research studies can make a difference to the many that suffer from chronic metabolic conditions. We strive to be the best at what we do and at all times be meticulous in all our practices placing the care, safety, and confidentiality of our volunteers first. Excellence in clinical research, accelerating access to treatments that change lives.
Together with Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, Headlands Research is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.
The Role
AMCR is looking for a Clinical Research Licensed Practical Nurse (see other posting for RN) to be responsible and accountable for the direct care of a group of research subjects during a designated time frame. The Clinical Research Licensed Practical Nurse (LPN) is a licensed clinical professional working with and under the direction of the Principal Investigator, Assistant Director, Lead Research Nurse, and in close conjunction with the Clinical Project Manager on early or late phases of clinical trials related to the treatment of diabetes. The Clinical Research Nurse is an integral member of the clinical trial team and assumes responsibility and accountability for the direct research care of a group of research subjects during a designated time frame. Nursing practice is focused on subject’s safety, IV placement and management, data collection, research subject’s satisfaction, and teamwork.
Position Type: PRN/Per Diem (Shift may range from 4 to 12 hours)
Pay Range: $32-$45/hr
Location: Escondido, CA
Travel: 0%
Work Schedule: Mondays through Fridays, 8:00am to 8:00pm (Shift may range from 4 to 12 hours)
Responsibilities
- Research / Regulatory:
- Contributes to data collection by adhering to “Good Documentation Practices”
- Documents in detail the data obtained following AMCR Institute’s Standard Operating Procedure (SOP).
- Competently recognizes signs and symptoms of Hypoglycemia, Hyperglycemia, and Ketosis and alerts the lead coordinator and clinician.
- Working knowledge of research protocol to understand the science behind the study.
- Assists research staff in specimen processing: spinning, pipetting, and analyzing using the YSI glucose instrument.
- Discharge research subject upon completion of in-clinic visit following the “Glycemic Discharge Protocol for AMCR Institute”.
- Clinical:
- Conducts a centered research subject assessment focusing on safety and venous access placement.
- Using aseptic technique, identifies the largest accessible vein and starts intravenous placement (IV) on adults and pediatric research subjects. Number of IV lines depending on the research design. May place two (2) IV lines on the same arm and/or another line on the opposite arm. “Please refer to attached Venous Access Protocol”.
- Using aseptic technique, changes IV bags PRN and adjust infusion pumps flow rate.
- Employs strategies in maintaining subject’s safety: monitoring heating pad temperature, awareness of blood glucose levels, phlebitis.
- Administers research drugs and/or medications as ordered by a clinician.
- Using aseptic technique, assists research staff in blood drawing using a 3-way stopcock method.
- Assists research staff with performing vital signs and EKG tracings.
- Provides the tools and necessary support to subjects in learning their diabetes management responsibilities in accordance with the protocol.
- Provides nursing support to staff regarding diabetes issues as needed.
- Organizes and prioritizes workload to effectively accomplish goals.
- Communication
- Communicates clearly and effectively with clinicians, nursing and research staff, and research subjects.
- Check-in and report with the Lead Research Coordinator and/or RN at the start and end of each shift and provide a complete outgoing report.
- Sign / initial / and date all documents that were worked on during shift prior to leaving.
Qualifications
- Must have current and unencumbered LPN license in the state of California
- CPR certification required (ACLS preferred)
- 3+ years clinical experience as an LPN strongly preferred (less may be considered depending on clinical rotations or type of experience)
- IV skills and phlebotomy experience required
- Experience in frequent, timed, venous sampling preferred
- Experience with diabetes-related medical devices a plus
- Experience in diabetes management and/or clinical trials a plus
Overview
The Headlands Research - AMCR Institute is dedicated to attracting, nurturing, and retaining patients and staff in order to carry out outstanding metabolic research. Our volunteers, sponsors, partners, and staff enjoy working together in an environment of mutual respect that fosters personal growth and optimal health. We passionately believe that the participation of a few in clinical research studies can make a difference to the many that suffer from chronic metabolic conditions. We strive to be the best at what we do and at all times be meticulous in all our practices placing the care, safety, and confidentiality of our volunteers first. Excellence in clinical research, accelerating access to treatments that change lives.
Together with Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, Headlands Research is in high growth mode; we operate more than 15 clinical trial sites in the US and Canada and have rapid expansion plans.
The Role
AMCR is looking for a Clinical Research Coordinator to coordinate and plan research study-related activities. This person will be responsible for ensuring day-to-day adherence to protocol, regulatory standards, and established policies and practices to deliver high quality and timely study data.
Position Type: Full-Time
Pay Range: $18-$20/hr
Location: Escondido, CA
Travel: 0%
Work Schedule: Mondays through Fridays
Responsibilities
- Enter clinical trial data collected during study visits into various web-based electronic data capture (EDC) programs.
- Responsible for resolution of data queries.
- Responsible for following up with clinic staff for outstanding queries.
- Review all data for errors and report any unusual findings.
- May perform quality control of source documents and EDC.
- Adhere to GCP, ICH, HIPAA, FDA Regulations and SOPs.
- Support the implementation and maintenance of an electronic QMS (eQMS).
- Support users of eQMS with regards to:
- Access control
- Workflow & required approvals
- Development of training materials
- Attend study teleconferences and meetings.
- File study paperwork in regulatory binders as needed.
- File subject charts in appropriate locked cabinets as needed.
- Complete accountability logs as needed.
- Comply with all regulatory requirements.
- May complete study visit paperwork (known as Case Report Forms, or CRFs) under the guidance and direction of the CTM and/or Study Coordinator.
- May perform other delegated duties as needed.
- Regulatory team support in collection, tracking and updating eReg system.
Qualifications
- High school diploma or equivalent degree is required.
- Exceptional organizational skills, diligence and follow through.
- Excellent verbal and written communication skills.
- Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors, and external customers.
- Exceptional knowledge of office computer systems and software
- Ability to effectively work within record software and update files accurately
- Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
- Must possess a high degree of integrity and ability to maintain confidentiality with patient, customer, and company’s sensitive information.
- High school diploma or equivalent degree is required.
- Exceptional organizational skills, diligence and follow through.
- Excellent verbal and written communication skills.
- Well-developed interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors, and external customers.
- Exceptional knowledge of office computer systems and software
- Ability to effectively work within record software and update files accurately
- Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic.
- Must possess a high degree of integrity and ability to maintain confidentiality with patient, customer, and company’s sensitive information.