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Care Access · 1 month ago

Sub-Investigator

Dalton, Georgia, United States

Full-time

Onsite

Senior Level

5+ years exp

Care Access is dedicated to improving health services and clinical research accessibility for communities facing barriers to care. The Sub-Investigator will support clinical research studies through regional travel and remote telemedicine work, ensuring compliance with study protocols and performing various clinical tasks related to investigational products.

Clinical TrialsHealth Care

No H1B

Responsibilities

Work closely with the Principal Investigator to oversee the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and other state and local regulations as applicable

Attends and participates in meetings with the director, other managers, and staff as necessary

Complies with regulatory requirements, policies, procedures, and standards of practice

Read and understand the informed consent form, protocol, and investigator's brochure

Be available to see subjects virtually or in-person as dictated by project design, answer their questions, and resolve medical issues during the study visit

Sign and ensure that the study documentation for each study visit is completed

Perform all study responsibilities in compliance with the IRB approved protocol

Administration of Investigational Products (via subcutaneous, transdermal, intramuscular, intravenous, or oral routes)

Proficiency in starting, monitoring, and maintaining intravenous lines

Proficiency in phlebotomy, proper blood collection practices, and laboratory processing practices (can be learned)

Contribute as an active member of clinicians involved in the management of infusion or other investigational product related reactions

Maintain a clean, efficient clinical area to assure the highest standards of patient care

Follow safety and PPE procedures as well as maintain proper documentation of infusion procedures

Timely communications with internal teams, investigators, review boards, and study subjects

Perform trial procedures as per delegation which can include the following but not limited to:

Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment

Obtain informed consent per SOP

Administer delegated study questionnaires, as appropriate

Collect and evaluate medical records

Complete visit procedures and ensure proper specimen collection, processing, and shipment in accordance with protocol

Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc

Review screening documentation and approves subjects for admission to study

Review admission documentation and approves subject for randomization

Provide ongoing assessment of the study subject/patient to identify Adverse Events

Ensure that serious and unexpected adverse events are reported promptly to the Pl

Review and evaluates all study data and comments to the clinical significance of any out-of-range results

Perform physical examinations as part of screening evaluation and active study conduct

Provide medical management of adverse events as appropriate

Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance

Monitor patient progress on study medication

Other duties as assigned

Qualification

Nurse PractitionerClinical ResearchInfusion SkillsPhlebotomyClinical Practice (GCP)Medical TerminologyComputer SkillsEnglish ProficiencyCommunication SkillsTeam CollaborationOrganizational SkillsCritical ThinkingInterpersonal Skills

Required

Ability to check, perform, and document vitals as well as EKG (ECG)

Phlebotomy and expert IV skills

Excellent working knowledge of medical and research terminology

Excellent working knowledge of federal regulations, good clinical practices (GCP)

Ability to communicate and work effectively with a diverse team of professionals

Strong organizational skills: Able to prioritize, support, and follow through on assignments with good understanding of medical terminology

Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors

Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals

Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel

Ability to balance tasks with competing priorities

Critical thinker and problem solver

Curiosity and passion to learn, innovative, and able to take thoughtful risks while communicating concerns and mitigations

Good management and organizational skills, understanding of medical procedures

Exceptional interpersonal skills, willingness to the ability to work independently

Ability to lift a minimum of 50 pounds

Command of professional and Business English (written and spoken)

You must have the authorization to work in the US for any employer

You must not need visa sponsorship, either now or in the future

You must live in the USA and be willing and able to travel with 24–36-hour notice

At least Master's Level Science Degree. Nurse Practitioner or Physician Assistant with 5+ years of clinical experience