APP Sub-Investigator/Clinical Trial Rater

APP Sub-Investigator/Clinical Trial Rater

M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

We are looking for an APP Sub-Investigator/Clinical Trial Rater to join our growing team. This position is an onsite, full-time role traveling between our Mission Viejo, CA and Encino, CA sites.

Job Description

The Sub-Investigator/Rater provides oversight in medical and clinical issues, as requested or required. The sub-investigator works with the Principal Investigator (PI) to evaluate clinical trials and ensure that all study-related procedures are completed in accordance with Good Clinical Practices (GCP). The sub-investigator performs critical trial-related procedures and makes important trial-related decisions when delegated by the PI. Sub-investigator is engaged in the informed consent process and has a significant role in the conduct of research. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study participants according to protocols, and for protecting the health, safety, and welfare of research participants. In addition, sub-investigator may also act as the study coordinator as indicated.

Essential duties and responsibilities including, but not limited to the following:

• Provides participant consultations and education in an in- or out-patient setting under the direction of the PI in charge of the clinical trial.
• Conducts study-related physical exams and follow-up visits.
• Administers semi-structured test or rater scales as per protocol, not limited to CDR, ADAS-COG, MMSE, CSSRS, Cognitive Battery Test, ESS, and like validated scales.
• Reviews and adheres to assigned research study protocols.
• Works with the study-leading PI in evaluation and review of potential study participant eligibility.
• Maintains proper documentation in accordance with GCP.
• Ensures that all clinical activities are carried out in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
• Collaborates with multidisciplinary team members.
• Reviews lab results, imaging reports, and other study-specific reports.
• Reviews and verifies participant medical history collected by the Wake Research Staff/Clinicians.
• Communicates with the participant as well as the participant's partner/informant/caregiver.
• Attends and successfully completes all training programs in a timely manner.
• Attends, participates in, and completes ongoing conference calls, webinars, required meetings, and other professional development opportunities.
• Completes required necessary training, Good Clinical Practice (GCP) training, and any Sponsor required trainings.
• Conducts participant interviews following specific study protocols, FDA, GCP, ICH, and HIPAA Privacy guidelines.
• Maintains knowledge and education of all applicable rules, regulations, policies, laws and guidelines respective to their field and role.
• Supports site operations for community outreach recruiting efforts and participant retention.

Qualifications

Education and training required:

• Master's degree OR equivalent combination of relevant education, training, and experience.
• Licensed Advanced Practice Registered Nurse (APRN) successful completion of an accredited through the Commission on Collegiate Nursing Education (CCNE) or the Accreditation Commission for Education in Nursing, Inc. (ACEN).
• Physician Assistant (PA-C) successful completion of an accredited Physician Assistant Program recognized by the Accreditation Review Commission on Education for the Physician Assistant (ARC-PA) or its predecessors.
• Current license to practice in the state of hire.
• No history of license suspension or debarment in any state or by the FDA.
• Must have BLS and ACLS certifications; PALS required if pediatric experience needed at site.

Minimum experience:

• Trained in phlebotomy.
• Experience in bedside procedures is preferred.
• 2 years of clinical practice experience is required.
• 2 years of clinical research experience as a sub-investigator is preferred.
• Pediatric experience is preferred.

Knowledge, skills, and abilities:

• Qualified candidates must have a minimum of 1 year experience performing psychometric rating scales in a clinical setting or for clinical trials.
• Preferred: Current or previous certifications to rate the following scales: MMSE, RBANS, GDS-15, QoL-AD, A-IADL-Q-SV, SCID-5-CT, MINI, LSAS, HAM-A/D, C-SSRS, MADRS, MGH-ATRQ, ISI, CGI, HDRS-17, PANSS, YMRS, ADAS-Cog, CDR.
• Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills.
• Strong written and verbal communication skills.
• Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams.
• Excellent verbal and written communication skills required.
• Ability to work independently, prioritize effectively and work in a team environment required.
• Sound knowledge of FDA regulations, ICH-GCP and International Organization for Standardization (ISO) standards.
• Strong written and verbal communication skills.
• Strong computer skills in appropriate software and related company and Sponsor clinical systems is required.

Additional Information

M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.

Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.

Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.

A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

*M3 reserves the right to change this job description to meet the business needs of the organization