Clinical Research Sub-investigator (PA/NP)

Kelly® Science & Clinical is seeking a Sub-Investigator for a fulltime, direct-hire position with a research site in Tampa, FL.

If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Physician Assistant / Nurse Practitioner

Job Description Summary :

PA / NP working under the direction of a Physician is responsible for management of the integrity of the conduct, and reporting of the research project;

and for managing, monitoring, and ensuring the integrity of any collaborative relationships. Additionally, is responsible for the direction and oversight of compliance, personnel, and other related aspects of the research project to assure research is conducted in accordance with federal regulations and sponsoring agency policies and procedures.

Although they may have administrative staff to assist them with the management of trials, the ultimate responsibility for the responsible for study conduct with Physician oversight.

Duties and Responsibilities :

The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all inclusive.

1 . Pre-Study Management : a. Protocol evaluation :

• Read and maintain general understanding of Investigational Brochure as it relates to the protocol.
• Assist in development of protocol design, if applicable
• Understand the trial design including its clinical, scientific, statistical, and ethical integrity.
• Provide protocol feedback to Sponsor / Contract Research Organization (CRO). b. Site Preparation and Initiation :
• Oversee investigational staff and support appropriate training of the staff in compliance with Good Clinical Practice (GCP) with the protocol.

2. Study Related Activities : a. Responsibilities and Obligations

• Conduct research in accordance with the clinical trial agreement
• Facilitate or verify formal approvals according to International Conference on Harmonization (ICH) Good Clinical Practice (GCP)and any regional, state and federal requirements.
• Oversee progress reports to Institutional Review Board annually, or as requested.
• Ensure compliance with regional requirements, such as Food and Drug Administration and ICH GCP, as applicable.
• Maintain current knowledge of clinical research issues (e.g., ICH GCP guidelines).
• Follow Heath Insurance Portability and Accountability Act (HIPAA) regulations. 2 Principal Investigator / Sub-Investigator Created : 01 / 24 / 2023 2
• Maintain communication with the IRB regarding continuing review, Serious Adverse Event (SAE), Investigational New Drug (IND) safety reports, protocol amendments, protocol deviations / violations, Informed Consent Form (ICF) modifications, final report, changes to Investigator agreement.
• Oversee recruitment department, receive updates on recruitment objectives and timelines.
• Assure subjects meet Inclusion / Exclusion criteria for the protocol.
• On-call 24 / 7 as required.
• Weekend on-site coverage for medical histories and physicals, and study drug administration, as required. b. Laboratory results
• Interpret laboratory values and alerts according to protocol and subject safety, document appropriately.
• Provide direct patient care as related to laboratory and clinical findings with subject related to protocol, for patients’ safety.

c. Adverse Events (AEs) and Serious Adverse Events (SAEs) :

• Determine causality of expected or unexpected results associated with investigational product.
• Document, classify, and manage adverse events.
• Assure proper medical care and follow up until resolution or stabilization of adverse events. d. Study Completion :
• Provide follow-up medical care for subjects, if applicable.
• Prepare for and respond to Sponsor / CRO, regulatory, or internal audits, questions, comments related to PI.

3. Subject Management : a. Recruitment

• Participate in the selection of trial subjects.
• Ensure compliance with data protection.
• Provide clinical services as directed by protocol : History and Physical ECG interpretation Clinical care for patient safety b. Informed Consent
• Ensure the protection of human subjects
• Explain study to subject and be available to answer any study-related questions
• Assess subject understanding of study requirements
• Obtain all required signatures
• Document obtaining ICF in source document c. Study Conduct
• Perform and / or supervise the conduct of study-related procedures and monitor the safety of the trial subjects and investigational staff
• Manage and motivate the investigational staff
• Establish and maintain professional relationships with trial subjects
• Facilitate effective communications with Sponsor, IRB, institution and regulatory authorities

4 . Documentation and Administration : a. Case Report Forms

• Review Inclusion / Exclusion criteria
• Collect accurate and verifiable data and other essential study documents i.e. : Medical History, Primary Physician follow up
• Data entry and validation as required by PI or Sub-I role per protocol b. Study Documentation
• Review other medical history as it relates to the patient and the protocol
• Assure query resolution with the Sponsor
• Maintain progress notes
• Document communication with study contacts
• Document protocol deviations / violations This job description is not an exhaustive list of all responsibilities that you may be required to perform.

Education / licenses / experience :

• College Degree (B.S. or M.S.)
• Graduated from an accredited School (PA / NP)
• Current FL State License
• Prefer 3-year practical clinical experience
• Prefer any research experience

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