Careers - High Point Clinical Trials Center
 

Careers

JOIN THE TEAM

Interested in joining the HPCTC team and contributing to global health? Qualified applicants may submit their resume or CV to our HR Department at hr@highpointctc.com.

CURRENT OPPORTUNITIES

Regulatory Specialist

Date updated: 06/21/2018

 

To establish, maintain and update regulatory activities and binder in a timely and organized manner.

 

Ensure confidentiality of and review, filing, storing, shipping and archiving of all essential regulatory study documents adhering to Federal Regulations, Good Clinical Practices (GCPs), ICH GCP Guidelines, Standard Operating Procedures (SOPs), state and local regulations where applicable

 

Essential Functions
  • Attends Site Initiation Visits (SIVs) and has working knowledge of protocols
  • Per Delegation of Authority, generates, collects, reviews and manages regulatory documentation for all clinical studies
  • Ensures all essential regulatory documents are submitted to the IRB and sponsor in a timely manner.
  • Communicates with IRB of record for each study regarding regulatory issues
  • Maintains regulatory binders
  • Communicates in a timely manner with sponsor regarding regulatory issues
  • Works closely with Principal Investigator (PI)/Medical Director regarding regulatory issues
  • Ensures delegation of duties is completed in a timely manner
  • Responsible for review and accuracy of all regulatory documents for adherence to GCPs, ICH GCP Guidelines, SOPs, study protocol, good documentation practices, grammar and typographical errors
  • Ensures essential documents are approved prior to use and the most current version of study documents are in use
  • Works closely with research study team ensuring that they are aware of approvals, amendments, Informed Consent Form (ICF) changes and any other issues that affect study conduct
  • Ensures all amended protocols, ICFs, etc. are tracked and immediately forwarded on receipt to study team.
  • Ensures all essential documents and internal and external study correspondences are promptly filed in regulatory files
  • Ensures all site reports, lab normal ranges, CLIA, certifications, Lab Director CVs are current
  • Timely submission of all IRB study status reports and end of study reports
  • Assists in the timely submission of all IRB study status reports and end of study reports
  • Works closely with investigators to ensure documents signed, filed and submitted in a timely/accurate manner.
  • Understands and adheres to project guidelines and timelines
  • Ensures confidentiality of all study documents
  • Trains staff in necessary regulatory issues
  • Reviews all Regulatory Documents prior to Sponsor/Monitor/auditor site visits
  • Meets with and be available to support auditors and sponsor study monitor inquiries and resolve regulatory queries during monitor or auditor visits or as soon thereafter, per study priority
  • Ensures study monitor provide signature on Monitor Sign-In Log daily for each visit
  • Ensures that at study close out all IP and laboratory documents are transferred to be stored with the regulatory files
  • Attends sponsor close out visits
  • Promptly reports issues of regulatory non-conformances to management and PI
  • Participate in any internal or external audit/inspections related to the regulatory function, Trial Master Files, SOPs and promptly secure regulatory compliance through corrective and preventative actions
  • At study close, track/ensure internal documents are current, on file (e.g., CV’s , licenses, certifications, training records)
  • Oversees study and regulatory document scanning process; ensure QC of each image, and packaging for archives.
  • Ensures site archiving checklist is completed accurately prior to archiving. Ensure safe transport to off- site archiving
  • Maintains training binders and ensures staff competencies are up to date
  • Assists in maintaining Document Control Room
  • Oversee staff training records, employee data base, building access and new hire orientation
  • Provides administrative support to Medical Director

 

Basic Qualifications
  • Strong knowledge of FDA regulations and GCP ICH guidelines with respect to regulatory documents
  • Proficient in word processing, and medical terminology
  • Excellent verbal, written, and organizational skills with team-oriented approach
  • Proficiency in Microsoft Office Suite, computer data bases (e.g., Access), EXCEL, spreadsheets and e-mail required

 

Preferred Qualifications
  • Two to four years of regulatory essential document completion, management and submission experience in a clinical research setting
  • Prior experience in Phase I or CRC certification helpful to fully understand the processes and procedures of a Phase 1 clinical research setting
  • Initiative to work independently and prioritization to work in team environment
  • Ability to take initiative, work independently or collaborate in teams, focus to handle multiple tasks to meet deadlines in fast paced environment is essential
  • Research Certification

 

Executive Administrative Assistant

Date updated: 06/06/2018

 

Provide administrative support for Mjalli Investment Group, LLC (MIG USA). Responsibilities include scheduling meetings and appointments, making office supplies arrangements, greeting visitors and providing general administrative support to our employees. A successful Office manager should also have experience with a variety of office software (email tools, spreadsheets and databases) and be able to accurately handle administrative duties.

 

Ultimately, the Office manager should be able to ensure the smooth running of the office and help to improve company procedures and day-to-day operation.

 

Essential Functions
  • Schedule meetings, appointments and manage office meeting rooms
  • Maintain the office condition and schedule necessary repairs
  • Provide general support to visitors
  • Assist HR with in-house or off-site activities, like parties, celebrations and conferences
  • Provide administrative assistance to all departments as required
  • Secure travel arrangements and maintain travel transaction records
  • Serve as daily backup for all front desk functions
  • Maintain and update company directory / Emergency contact list
  • Office supply orders/ inventory
  • Research and ordering of special items
  • Administrative support for Executives and Business Operations Staff
  • Implement and maintain spreadsheets as required for administrative transactions.
  • Manage courtesy cards, flowers and gifts on behalf of MIG USA. i.e. Holiday Cards, Bereavement, Thank You, etc
  • Review, document and distribute feedback from Employee and subject suggestion boxes

 

Basic Qualifications
  • Expert Computer skills, including; MS Word, PowerPoint, Excel, Outlook
  • Excellent written and oral communication skills
  • Must be able to work well under pressure in a fast-paced environment
  • Flexible schedule is a must

 

Preferred Qualifications
  • Prior Purchasing/Travel coordination experience
  • Excellent time management and critical thinking skills
  • Self-starter with excellent organizational skills
  • Ability to interact positively with all levels of staff and management
  • Knowledge of Medical Terminology
  • Positive public relation skills with the ability to provide positive first impressions to all visitors
  • Able to represent MIG USA in a professional manner at community events

 

Clinical Research Technician, Third Shift (Bilingual)

Date updated: 06/05/18

 

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation.

 

Duties and Responsibilities
  • Assist in the conduct of clinical studies while providing licensed coverage
  • Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines
  • Perform tasks such as EKG’s, vital signs, phlebotomy
  • Communicates in a timely manner with physicians regarding patient safety concerns, adverse events, protocol deviations, and any study conduct issues
  • Reads and has knowledge of study protocols
  • Ensures study participant’s confidentiality and HIPAA compliance
  • Flexible schedule is a must

 

Skills and Experience

Experience Requirements:

  • Strong organizational, supervisory, and interpersonal skills.
  • Excellent time management and critical thinking skills and the ability to multi-task.
  • Proficiency performing medical tasks to include taking vital signs, EKGs, phlebotomy.

Preferred Skills:

  • Bilingual (English and Spanish) candidates preferred

Licensure/Certification Requirements:

  • Current Phlebotomy or Medical Assistant Certification
  • Basic Life Support (BLS) certification

 

Shift

Third

 

Clinical Paramedic, Third Shift (Bilingual)

Date updated: 06/05/2018

 

Assists in the conduct of clinical studies. Provides EMS licensed coverage for studies and performs procedures as allowed by training and delegation.

 

Duties and Responsibilities
  • Assist in the conduct of clinical studies while providing licensed coverage.
  • Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines.
  • Administration of study drug and concomitant medications.
  • Communicate in a timely manner with physicians regarding patient safety concerns, adverse events, protocol deviations, and any study conduct issues.
  • Reads and has knowledge of study protocols
  • Ensures study participants confidentiality and HIPAA compliance.
  • Flexible schedule is a must.

 

Skills and Experience

Experience Requirements:

  • At least one year of practical emergency services experience preferred
  • Strong interpersonal, supervisory and organizational skills
  • Proficiency at performing tasks such as EKG’s, vital signs, phlebotomy, insertion and maintenance of IV catheters.
  • Excellent time management and critical thinking skills as well as the ability to multi-task

Preferred Skills:

  • Bilingual (English and Spanish)

Education Required:

  • High school graduate or GED required.

Licensure/Certification Requirements:

  • Active Paramedic Licensure and in good standing with the North Carolina office of EMS

 

Shift

First, Second, Third

 

Principal Investigator

Date updated: 05/4/2018

 

To conduct clinical research studies overseeing all aspects of the assigned studies and supervising the clinical trial(s) in accordance with 21 CFR part 312, Site SOPS, study protocols and other applicable regulations under the direction of the Medical Director.

 

Essential Functions
  • Performs all job responsibilities in accordance with standards of Good Clinical Practice(GCP), clinic SOPs, OSHA guidelines, Federal and local regulations
  • Signs the 1572 and abides by commitments as contained in the 1572 and 21 CFR Part 312.
  • Reports to Medical Director on all administrative, logistical and staff related site issues
  • Attends SIV, Eligibility and other meetings as required
  • Reads and has knowledge of study protocols and Investigator’s Brochure
  • Timely evaluation/sign-off of study documentation
  • Oversees overall clinical study(ies) functions including eligibility criteria, study participants
  • Supervises all appropriately delegated staff on medical matters during study conduct
  • Ensures adequate staff scheduling for study conduct
  • Completes necessary regulatory documents in a timely manner
  • Ensures that necessary documents are IRB approved prior to use
  • Ensures that studies are conducted according to protocol, HPCTC SOPs, and regulatory requirements
  • Ensures that all staff are trained and delegated in study related tasks
  • Responsible for protocol assessment, feasibility, and adherence
  • Conducts and oversees that informed consent is conducted in accordance with 21 CFR Part 50 and that informed consent is obtained prior to performing study procedures
  • Ensures IRB approval for the study is obtained in accordance with 21 CFR Part 56 and communicates with IRB and sponsor regarding study issues such as unanticipated adverse events, protocol deviations, adverse events (AE)and Serious Adverse Events (SAE)
  • Assists recruiting department in study participants recruiting as needed
  • Provides medical coverage for research studies as needed
  • Performs or Oversees Study participant education
  • Screens study participants to determine study participants eligibility and continuing eligibility
  • Documents, manages and follows up on adverse events
  • Documents, reviews, and identifies concomitant medications as needed; assigns causality of adverse events
  • Provides physician orders and writing of prescriptions as needed
  • Administers or reviews study specific questionnaires as needed
  • Administration of study drug and concomitant medications
  • Ensures staff are conducting procedures and activities as per protocol, clinic SOP’s and Good Clinical Practice Guidelines
  • Ensures procedures are conducted in an accurate and timely manner
  • Assists with review of external sponsor Requests for Proposals (RFPs)
  • Provides timely evaluation and sign-off of source documents and case report forms (CRFs)
  • Provides medical assessments/physical exams and management or referral for management of adverse events
  • Reviews and interprets EKGs, vital signs, laboratory tests, medical records, clinical evaluations, study specific questionnaires and assesses significance of out of range values
  • Arranges medical follow up of study participants as needed and arranges for repeat testing if indicated; counsels study participants regarding out of range or significant test results
  • Participates in Site Initiation Visits, safety meetings and dose escalation meetings as required
  • Works with study team and management regarding study and clinic needs
  • Maintains adequate and accurate records and case histories as per 21 CFR 312.62 and ensures records are readily available upon regulatory inspection
  • Utilizes an IRB that complies with 21 CFR Part 56 and reports all change in research activity and all unanticipated problems involving risks to human study participants to the IRB of record

 

Qualifications

Education and Experience

Basic Qualifications:

  • Medical Degree
  • Valid License in State of North Carolina
  • Current DEA License
  • Certification In Research
  • Basic Life Support (BLS) certification
  • Advanced Cardiac Life Support (ACLS) certification
  • Five to ten years of clinical experience

Preferred Qualifications:

    • 2 – 5 years of experience in conducting clinical trials with Phase 1 experience
    • Strong organizational, supervisory and interpersonal skills
    • Ability to interact positively with all levels of staff and liaise successfully with all levels of management
    • Able to represent HPCTC in a professional manner at community events
    • A strong team player
    • Excellent verbal and written communication skills, presentation skills, as well as computer skills
    • Excellent time management and critical thinking skills
    • Multi-tasking capabilities
    • Positive public relations skills with ability to provide positive first impressions to all visitors
    • Previous management experience preferred

 

Senior Clinical Research Coordinator

Date updated: 05/3/2018

 

Acts as a lead in the Clinical Research Coordinator Team supporting the Vice-President of Clinical Pharmacology Services in the clinical conduct of research studies at the clinical research center.

 

Essential Functions
  • Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic SOPs, OSHA guidelines, Federal and local regulations
  • Completes all required training programs per company requirements and as applicable to study protocols
  • Reports to Vice President, Clinical Pharmacology Services on all administrative, logistical, staff related site issues
  • Responsible to the Principal Investigator (PI) on all medical and compliance aspects of study conduct for specific studies
  • Ensures overall understanding of protocols and generally, serves as the back-up CRC on designated studies. May serve as a primary CRC as dictated by resource management, complexity of project, or other strategic considerations.
  • Mentors, but does not directly manage/supervise, more junior CRCs with operational oversight of clinical conduct to ensure compliance
  • Ensures Sponsor, CRO, and study participants confidentiality and HIPAA compliance
  • Attends Site Initiation Visit (SIV), and other study related meetings as required

 

As per Job Description and as trained and delegated by the Medical Director or Principal Investigator and as allowed by sponsor:

  • Leads the development and creation of clinical source documents, tools, and processes
  • Ensures study binders and source documents are available for study conduct
  • Performs quality checks on study documents
  • Ensures documents are filed, organized and stored properly and in a timely manner
  • Assists in ensuring activity time points are met
  • Assists regulatory staff as needed
  • Ensures study data entry and query resolution is completed in a timely manner
  • Assists with training documentation and coordinating staff training
  • If trained and delegated, performs study procedures (including EKGs/vital signs/meals/phlebotomy and lab processing)
  • Organizes study supplies and overseeing study logistics
  • Assists with recruitment activities and represents company at community events
  • If delegated, performs informed consent process, and collects medical histories

 

Qualifications

Education and Experience

Basic Qualifications:

  • Bachelors Degree or Higher in related, science or medicine related major.
  • Previous clinical research experience (10+ years) preferred.
  • Ability to work under pressure in a fast-paced environment with parallel and competing priorities
  • Ability to work in compliance in a highly regulated environment

Preferred Qualifications:

    • Excellent verbal and written communication skills, presentation skills, as well as computer skills.
    • Computer skills, including MS Word, PowerPoint, Excel, Outlook
    • Excellent time management and critical thinking skills.
    • Robust (10+ yrs) previous experience in a clinical research unit or CRC certification.
    • Competent in performing medical tasks (such as taking vital signs, EKG, drawing blood, etc.)
    • Ability to interact positively with all levels of staff and liaise successfully with all levels of management.
    • Flexible Schedule
    • Positive public relations skills with ability to provide positive first impressions to all visitors.
    • Able to represent HPCTC in a professional manner at community events and meetings
    • A strong team player.

 

Proposals and Business Analyst

Date updated: 05/1/2018

 

This individual is responsible for developing detailed budgets and/or proposals focused on client solutions that are aligned with HPCTC operational strategy of executing early phase clinical research studies conducted at the clinical trials research center. Excellent ability to process multiple activities and priorities. This position reports to the Head of Business Development.

 

This role is primarily responsible for RFPs, complex RFIs, and related client deliverables. Ensures all documents align appropriately with the HPCTC operational strategy and budget, completed within appropriate timelines and to high quality standards.

 

Essential Functions
  • Interprets and analyzes appropriate data to build budgets and write proposals. Supports or manages Saleforce.com database as directed to provide analysis and report metrics (sales funnel, BD activities, etc.).
  • Ensures the proposal, budget and related documents align with operational strategy; including creation of supporting material. Assures accuracy, consistency and competitiveness of budgets.
  • Supports Business Development team in bid defense preparation and any other related deliverables
  • Supports cross functional team solutions regarding BD-related escalations and client requested changes or solution defects.
  • Participates with development and implementation of departmental or cross-functional process improvement or corporate initiatives.
  • Represent company and team during client and team meetings.

 

Qualifications

Education and Experience:

  • Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
  • Track record of producing Phase I/II clinical operations budgets from protocols and/or synopses over a minimum of 3+ years or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities:

  • Strong project management skills and ability to process multiple activities and priorities
  • Strong financial acumen as related to business processes up to and including forecasting, study milestone reconciliation and interacting with accounting team members.
  • Excellent judgment and decision-making skills
  • Excellent oral and written communication skills Ability to work well under pressure
  • Excellent interpersonal, organizational and negotiation skills and problem-solving ability
  • Strong knowledge of clinical development process including functional operations and regulatory guidelines and directives across full spectrum of development activities
  • Strong expertise in sales and marketing strategy
  • Strong relationship builder who can work effectively with external and internal clients
  • Excellent computer and graphics skills including Word, PowerPoint, Excel and others.
  • Ability or experience in Salesforce.com or equivalent Client Relationship Management tool.

 

Lab Technician

Date updated: 05/10/2018

 

Assist Lab Manager in collection and processing of lab specimens. Perform study required laboratory tests in accordance with study protocol, company SOP’s, Occupational Safety and Health Administration (OSHA) and international Air Transport Association (IATA) requirements.

 

Essential Functions
  • Completes all study procedures as per FDA regulations, GCP guidelines and protocol requirements
  • Assists with and performs laboratory procedures including sample check-in, preparation, centrifugation, storage and shipment
  • Assists with temperature monitoring and control of laboratory sample environments
  • Has experience with clinical sample handling and maintenance of a chain of custody
  • Packs and ships specimens
  • Reviews lab documents for completion and accuracy
  • Team player and self-motivated individual prepared to present themselves to pharmaceutical representatives when necessary

 

Qualifications

Experience Requirements

  • Minimum 1 year Lab experience
  • Knowledge of onsite testing procedures

Education Required

  • High school graduate or GED required.
  • CLS/MT Associates, BS, BA degree preferred

Licensure/Certification Requirements:

  • Phlebotomist Certification preferred.

 

Research Nurse

Date updated: 04/27/2018

 

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation.

 

Duties and Responsibilities
  • Assist in the conduct of clinical studies while providing licensed coverage.
  • Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines.
  • Perform tasks such as EKG’s, vital signs, phlebotomy, insertion and maintenance of IV catheters.
  • Administration of study drug and concomitant medication.
  • Communicates in a timely manner with physicians regarding patient safety concerns, adverse events, protocol deviations, and any study conduct issues.
  • Reads and has knowledge of study protocols
  • Ensures study participant’s confidentiality and HIPAA compliance.
  • Flexible schedule is a must.

 

Skills and Experience

Experience Requirements:

  • At least one year of practical nursing experience preferred.
  • Strong organizational, supervisory, and interpersonal skills.
  • Excellent time management and critical thinking skills and the ability to multi-task.
  • Proficiency performing medical tasks to include taking vital signs, EKGs, phlebotomy, insertion and maintenance of IV catheters.

Education Required:

  • LPN/RN, or diploma in nursing.

Licensure/Certification Requirements:

  • Active North Carolina nursing license
  • Advanced Cardiac Life Support (ACLS) certification
  • Basic Life Support (BLS) certification
  • Current registration and in good standing with North Carolina Board of Nursing

 

Shift

First, Second, Third