Qureos Mentor

Pinnacle Clinical Research

<div><p><b>Summary:</b> Assists the Clinical Research Coordinator and the principal investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), International Council for Harmonization Good Clinical Practice (ICH GCP), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.</p><p><b>
Duties and Responsibilities:</b></p><ul><li>
Assists with the creation and completion of study related documents and new study preparation.</li><li>
Assists with the completion of regulatory submissions and maintains regulatory files as directed.</li><li>
Acts as a secondary liaison with sponsors.</li><li>
Assists with the preparation for study monitor visits as directed.</li><li>
Completes case report forms as directed.</li><li>
Creates reports as requested.</li><li>
Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.</li><li>
Assists with subject screening and recruitment as directed.</li><li>
Updates Clinical Trial Management Software (CTMS) as directed.</li><li>
Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.</li><li>
Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.</li></ul><p><b>
Education/Experience:</b></p><p>
High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.</p><p><b>
Certificates and Licenses:</b></p><ul><li>
Clinical research certification preferred</li></ul><p><b>
Knowledge, Skills, and Other Abilities:</b></p><ul><li>
Ability to demonstrate competence in oral and written communication</li><li>
Bilingual (English/Spanish) required</li><li>
Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor</li><li>
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner</li><li>
Medical knowledge, including medical terminology</li><li>
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.</li><li>
Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.</li></ul><p><b>
Work Environment and Physical demands:</b></p><p>
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.</p><ul><li>
Work is performed in an office/laboratory and/or a clinical environment.</li><li>
Exposure to biological fluids and/or bloodborne pathogens.</li><li>
Personal protective equipment required such as protective eyewear, garments, and gloves.</li><li>
Occasional travel may be required domestic and/or international.</li><li>
Ability to work in an upright and/or stationary position for 6-10 hours per day.</li><li>
Frequent mobility required.</li><li>
Occasional squatting, kneeling, or bending.</li><li>
Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.</li></ul><p><b>
Perks of working at Summit Clinical Research Solutions:</b></p><ul><li><i>
401k</i></li><li><i>
Medical, dental, vision, long term disability, short term disability, FSA, and life insurance</i></li><li><i>
3 weeks of paid time off</i></li><li><i>
14 paid company holidays</i></li><li><i>
Scrub voucher (specific positions apply)</i></li><li><i>
And more!</i></li></ul><p>
Summit Clinical Research Solutions is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.</p></div><p></p>

Clinical Research Assistant

<div><div><b>Summary:</b> The PRN Laboratory Technician will be responsible for running the day-to-day operations of the lab. They will aid in research related activities and clinical research including collecting blood, urine/stool or tissue samples, and processing/shipping biological samples, as well as maintaining all laboratory documentation and supplies. This person must have a minimum of 12 months of laboratory experience in a healthcare setting and be able to understand laboratory priorities and establish a workflow to complete all required activities in a timely manner.</div><div>
The PRN Lab Technician must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the Summit Pinnacle Clinical Research team and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, self-motivated, and a team-player. This role reports directly to the Laboratory Manager or the site Clinical Research Operations Manager.</div><div>
</div><div><b>
Duties and Responsibilities:</b></div><ul><li>
Perform lab tests, collect subject specimens, and process samples according to corresponding study lab manual</li><li>
Responsible for daily phlebotomy (venipuncture, IV catheter or capillary collections) and specimen processing, and biological sample shipping using universal precautions</li><li>
Uses proper tools such as appropriate needle gauge and type of needle (straight needle, butterfly, or IV catheter) and judgment to obtain optimum specimens while minimizing discomfort and hazards for the patient</li><li>
Collect, organize, store, and ship samples in accordance with quality control and all safety and other requirements to ensure the safety of personnel and integrity of the sample</li><li>
Ship processed specimens to the central and/or local lab in a timely manner and according to study lab manuals</li><li>
Track inventory of lab kits from the central lab and re-order as needed. Ensure there are no expired lab kits on premises</li><li>
Track inventory of lab supplies and shipping containers and re-order as needed</li><li>
Maintain a clean and sanitary laboratory area, storage area, and lab restroom always. Clean and maintain lab equipment, including alerting the Lab Manager or Clinical Research Project Manager when recalibration of equipment is needed</li><li>
Facilitating or advising lab manager/project manager for biohazard pickups</li><li>
Complete and upload lab requisitions into Clinical Research IO (CRIO) and subject folders daily, as well as file the physical copies</li><li>
Distribute lab requisitions to appropriate CRC or Research Assistant daily for filing</li><li>
Receive and process deliveries for the lab (e.g. upload temperature logs into share drive, ensure product quantity matches shipping manifest, etc.).</li><li>
Maintain equipment records, temperature logs, inventory trackers, PK logs, and daily work logs in a timely manner</li><li>
Complete the required data entry daily and ensure inventory is tracked in a timely manner</li><li>
Retrieve subject specimens from local vendor locations if applicable (i.e. liver biopsy tissue)</li><li>
Communicates pertinent medical history information to appropriate coordinating staff</li><li>
Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures under the direction from the study Investigator and supervisor</li><li>
Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel and clinical trial patients</li></ul><div><i>
Duties, responsibilities, and activities may change, or new ones may be assigned at any time.</i></div><div>
</div><div><b>
Qualifications:</b></div><ul><li>
High school diploma or equivalent is required</li><li>
Certified in phlebotomy preferred with at least 1 year of experience</li><li>
Strong verbal and written communication skills</li><li>
Must complete CITI and GCP training before interacting with participants and must re-certify every 3 years</li><li>
Must complete IATA Dangerous Goods Training and re-certify every 2 years</li><li>
Must complete basic life support (BLS) training (training will be provided by PCR)</li><li>
Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS</li><li>
Valid driver's license with maintenance of safe driving record and an automobile that is insured in accordance with the state</li><li>
Flexibility with work schedule- early shifts, late shifts, weekend shifts</li><li>
Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time</li><li>
Intermediate-level knowledge of medical terminology</li><li>
Possess impeccable integrity and personal and professional values that are consistent with PCR&rsquo;s high standards and mission</li><li>
Comply with the company policies, code of ethics, and guiding values always</li><li>
Proficient in English and Spanish preferred</li></ul><div><b>
Competencies:</b></div><ul><li>
Must be able to effectively communicate with all levels of internal and external contacts</li><li>
Ability to work independently and multi-task in a fast-paced team environment</li><li>
Strong people skills including the ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment</li><li>
Strong organization and time management skills with an elevated level of attention to detail</li><li>
Ability to quickly learn and process information</li><li>
Must be able to work independently and collaborate with a team</li><li>
Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment</li><li>
Ability to interpret clinical research protocols and lab manuals</li><li>
Strong problem-solving and decision-making skills, particularly when under pressure</li><li>
Proactive at identifying, addressing, and solving issues in real time</li></ul><div><b>
Work Environment and Physical demands:</b></div><div>
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.</div><ul><li>
Work is performed in an office/laboratory and/or a clinical environment.</li><li>
Exposure to biological fluids and/or bloodborne pathogens.</li><li>
Personal protective equipment required such as protective eyewear, garments, and gloves.</li><li>
Occasional travel may be required domestic and/or international.</li><li>
Ability to work in an upright and/or stationary position for 6-10 hours per day.</li><li>
Frequent mobility required.</li><li>
Occasionally squatting, kneeling, or bending.</li><li>
Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.</li></ul><p></p><div><br>
Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.</div></div>

PRN Lab Technician Phlebotomist

Join Pinnacle Clinical Research and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Pinnacle Clinical Research

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Clinical Research Assistant

PRN Lab Technician Phlebotomist