Advanced Practice Provider - Sub Investigator

Pinnacle Clinical Research- A Summit Solution; Houston (TX); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision ins.

Paid time off

Tranquility Room

Pinnacle Gym

Scrub voucher

Job summary

Pinnacle Clinical Research- A Summit Solution is seeking a Clinical Research Nurse Practitioner/Physician Associate to join as a sub-investigator on ongoing study protocols. The role involves following up visits, reviewing labs, recruiting subjects, and collaborating with the clinical operations team.

Candidates should hold an advanced degree, an active ARNP/PA license, and GCP training is preferred. Expect work in office/lab and clinic environments with travel as needed.

Qualifications

• Advance degree from a graduate school and one to two years related experience.
• Current advanced registered nurse practitioner or physician assistant license.
• GCP Training certification preferred.

Responsibilities

• See follow-up visits and review labs for study subjects.
• Recruit subjects into protocols.
• Coordinate with the clinical operations team and affiliates.
• Perform study procedures including physical examinations and informed consent.
• Maintain confidentiality and comply with sponsor requirements and regulations.
• Assist in study monitor visits preparation.
• Screen and recruit subjects as per protocol directives.
• Communicate with physicians, nurses, and sponsor reps.

Skills

Written & oral communication

Interpersonal skills

Attention to detail

Flexibility with priorities

Education

Advanced degree (graduate school)

Current ARNP/PA license

GCP training preferred

Valid driver’s license

Tools

Microsoft Office

Internet Explorer

Google Chrome

Mozilla Firefox

Job description

Summary: The Clinical Research Nurse Practitioner/Physician Associate will be listed as a sub-investigator on all ongoing study protocols. She/He will be a key member of the team and will be responsible for seeing follow up visits, reviewing labs for study subjects, recruiting subjects into protocols, and working with the clinical operations team.

Duties and Responsibilities:

• Works with affiliates or collaborating research sites.
• Maintains subject and document confidentiality at all times and understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice, International Conference on Harmonization, Health Insurance Portability and Accountability Act, Institutional Review Boards, and institutional policies and procedures.
• Performs study related procedures such as physical examinations, informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessments.
• Reviews and holds expert knowledge of study related activities and protocols.
• Adheres to study protocols, Food and Drug Administration regulations, and good clinical practices at all times.
• Assists in the preparation for study monitor visits.
• Performs subject screening and recruitment.
• Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the principal investigator.
• Interacts with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.
• Coordinates multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume.

Education/Experience:

• Advance degree from a graduate school; and one to two years related experience and/or training; or equivalent combination of education and experience. Specialized training.
• Certificates and Licenses:
• Current advanced registered nurse practitioner or physician assistant license.
• Valid driver’s License
• GCP Training certification preferred

Knowledge, Skills, and Other Abilities:

• Written and oral communication skills

Organizational skills

• Ability to pay attention to detail
• People skills including possessing a positive, friendly, and professional demeanor
• Ability to be flexible with changing priorities
• Ability to communicate in a diplomatic and professional manner
• Strong interpersonal skills
• Strong mathematical knowledge

knowledge of Microsoft Office, Internet Explorer, Google Chrome, Mozilla Foxfire, and web-based enterprise solutions software.

Work Environment and Physical demands: 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.

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment is required such as protective eyewear, garments, and gloves.
• Occasional travel may be required domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Perks of working at Pinnacle Clinical Research:

• Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
• 3 weeks of paid time off
• Tranquility Room (specific locations apply)
• Pinnacle Gym (specific locations apply)
• Scrub voucher (specific positions apply)

And more! 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