Research Regulatory Specialist
African Clinical Research Limited (ACR)
7d ago
source : myJobmag
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    African Clinical Research Limited (ACR) is a wholly indigenous Site Monitoring Organization founded with the goal of bringing health to all Africans through the latest advances in Clinical Research by being exceptionally responsive to the needs of the medical community and to exceed expectations in every aspect of the services we provide.

    We have a solid team of research professionals (Physicians, Coordinators etc.) dedicated to our goal.

    Job Description

    An exciting new job opportunity has opened for a suitable candidate to develop, implement and deliver top-notch managerial relationship and attitude for African Clinical Research Limited.

    A passion for technology and project delivery focused is required.

    Job Responsibilities

    Oversees day-to-day business operationsProvides leadership to all levels of the organizationCommunicates and embody the company’s vision and valuesBuilds up the company by interviewing, hiring, and mentoring new talentDefines and implement policies and performance standardsEvaluates employee performance and provide additional coaching and support as neededAssesses departmental and company performance and devises plans for improvementManages profit and loss statements and accounts for costs and revenuesAllocates budget resources for supplies, equipment, marketing, and personnelSupports clinical research team (physicians, nurses, etc.

    in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial’s duration for research studies involving human subjects.

    Establishes and maintains processes and also monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies, procedures, and regulations.

    Manages identified issues and provides feedback to leadership regarding resolution.Disseminates information and participates in training.

    Provides direction and feedback to the research team to ensure awareness of business practices and quality standards.Documents any exceptions to compliance standards.

    Manages new submissions and continuing review activities.Reviews initial submissions to determine the review category and action to be taken.

    Completes submission applications, and other required documentation prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.

    Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).

    Completes protocol renewal applications, amends applications and maintains the record of all adverse event reports.Attends research team meetings and reports on regulatory issues.

    Responsible for administrative duties corresponding to budgets and contracts.Performs related responsibilities as required.

    Education :

    B. Pharm / MBBS. MBA preferred.

    Knowledge, Skills & Experience :

    Market knowledgeEnglish language fluencyOral, written & presentation skillsAbility to build strong relationshipsGeneral sales skills, including need identification, questioning, listening, negotiation and closing.

    Strategy development skillsMotivated, dynamic & industrious with can-do attitude.Personable & professional appearanceGood commercial acumen.

    Past managerial experience required.

    Position Summary

    The Research Regulatory Specialist (RRS) position oversees the daily regulatory activities for research studies and coordinates and performs administrative research support services.

    The primary focus of the RRS will be the achieving and maintaining compliance with all internal, external and federal policies and regulations that apply to the conduct of clinical trials at African Clinical Research Limited.

    Essential Duties

    Prepares study documents for submission to the IRB, sponsor or other regulatory authority and corresponds appropriately with these bodies.

    Coordinates and performs study specific regulatory processes across multiple studies of different therapeutic areas.Provides regulatory guidance, direction, and support to all members of the research team at ACRPerforms a variety of administrative research tasks in support of the study startup team.

    Ensures regulatory compliance with all internal, external, federal and state policies, procedures and regulations.

    Other Duties : None

    Competencies :

  • Accountability : Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness;
  • confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals;
  • demonstrates a commitment to National Jewish Health.Adaptability : Maintaining effectiveness when experiencing major changes in work responsibilities or environment;
  • adjusting effectively to work within new work structures, processes, requirements, or cultures.Attention to Detail : Accomplishing tasks by considering all areas involved, no matter how small;
  • showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time.

  • Setting high standards of performance for self and others; assuming responsibility and accountability for successfully completing assignments or tasks;
  • self-imposing standards of excellence rather than having standards imposed.Collaboration / Teamwork : Cooperates with others to accomplish common goals;
  • works with employees within and across his / her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor;
  • values the contributions of others.Decision Making : Identifying and understanding issues, problems, and opportunities; comparing data from different sources to draw conclusions;
  • using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.

    Supervisory or Managerial Responsibility :

    Travel : None.

    Education :

    Bachelor's degree required.

    Work Experience :

    A minimum of 2 years relevant regulatory clinical research experience required.

    Special Training, Certification or Licensure :

    Core Values :

    Be available to work as scheduled and report to work on time.Be willing to accept supervision and work well with others.

    Be well groomed, appropriately for your role and wear ID Badge visibly.Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct.

    Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.

    Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.

    Demonstrates compliance with all state, federal and all other regulatory agency requirements.

    Method of Application

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