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Clinical Research Associate I

Romark, L.C


Location:
Tampa, Florida
Date:
07/12/2017
2017-07-122017-08-11
Job Status:
Full Time
Categories:
  • Clinical Operations
Romark, L.C
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  • Research Salary

Job Details

As an entry-level CRA, will be responsible for monitoring activities of assigned clinical trials for the company’s investigational products, according to standard operating procedures (SOPs), ICH-GCP and other applicable regulations. Act as project resource to clinical trial site regarding the investigational product and the conduct of the clinical trial.

Essential Functions

Ensure compliance with protocol, standard operating procedures (SOPs) and other applicable regulatory policies, procedures and guidelines during clinical studies.

Participate in the design, administration and monitoring of clinical trials.

Monitor and tracks clinical study data (CRFs, source documents, diagnostic reports, inventory logs, etc.) to ensure the validity and integrity of study data.

Identify and resolve study data discrepancies and obtains missing study data. Track data query resolution.

Participate in the follow-up of adverse experiences by keeping timely and accurate documentation and appropriate communication of all Adverse Event reports per internal procedures and regulatory requirements.

Contribute to writing and designing Case Report Forms/Electronic Data Capture systems and other study aids for investigational products by addressing issues from a monitoring perspective.

Ensure timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation per procedures and regulations.

 Under supervision will:

  • Train investigators and study coordinators on proper protocols and procedures.
  • Conduct Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits.
  • Follow up on corrective actions at clinical sites.
  • Ensure proper product supply, accountability and storage during assigned clinical studies.
  • Other activities as necessary.

Qualifications

Education and/or Experience

  • High School degree. College degree ideal.
  • Knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials is ideal.
  • Familiarity with routine medical/scientific terminology ideal.
  • A basic understanding of clinical data flow ideal.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Ability to write reports and business correspondence.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Demonstrated ability to deal with confidential information.
  • Ability to work as part of a team, displays a commitment to service, be process oriented, and have a sense of urgency balanced with good judgement.
  • Individual will be a professional who is able to prioritize multiple and changing responsibilities while being organized & detail oriented.
  • Able to display effective interpersonal skills with all levels of people (both internally and externally) from a variety of different backgrounds and cultures, as well as the ability to positively and effectively communicate, verbally and in writing.
  • Strong integrity and work ethic are critical.
  • Able to anticipate problems.

 Core Competencies

  • Communication Proficiency
  • Thoroughness
  • Collaboration Skills
  • Problem Solving Skills
  • Ethical Conduct

 

Romark Core Values

Vision - Big vision, no limits; purpose-driven; ability to identify potential problems or impediments and to see through them

Competence - Exceptional knowledge and understanding of the work we are called to do; exceptional critical thinking skills

Ingenuity - Original, creative, clever, innovative, perceptive and/or intuitive in solving problems or meeting challenges

Courage - Willingness to take calculated risks to accomplish a noble mission

Passion - Intense compelling enthusiasm or desire to achieve our calling/fulfill our purpose

Integrity - Having a clear vision and understanding of that which is right and doing it; being faithful to patients and healthcare professionals

Relationships - Trusted business partners, engaging others with professionalism, grace and respect in valued long-term relationships

Personal Responsibility - Leadership, dependability, doing our jobs and going beyond the call to ensure success of the organization

Respect -Humility; exhibiting special appreciation for medicines, for our work, for the responsibilities and opportunities with which we have been entrusted

Perseverance - "In it to win it" – steadfast despite difficulty or delay

Excellence - Being outstanding or extremely good in everything we do

 Certifications, Licenses, Registrations

 None.

 Travel

 Ability and willingness to travel, including internationally, as needed up to 70%.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

 Qualifications

Education

Preferred

Associates or better in General Studies.