CRO-PT Contract Medical Monitor, Psychiatrist
Company: Evolution Research Group
Location: New Providence
Posted on: April 1, 2026
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Job Description:
Location: Remote Website: Lotus Clinical Research | Global CRO
for CNS, Pain, Obesity & Metabolic Trials with Integrated Site
Network About this role: Primary responsibilities include medical
and safety oversight of clinical trials. The Contract Medical
Monitor, Psychiatrist provides services to clinical trials with the
aim to monitor the safety and wellbeing of study participants,
integrity of the project data in accordance with the clinical trial
protocol/clinical study protocol (or equivalent documents),
standard operating procedures (SOPs), good clinical practice (GCP),
and all other applicable directives and regulatory requirements.
This role will be up to 20 hours per week with potential to
increase after Q1 2026. This project is long-term.
Responsibilities: Other duties may be assigned. Employee performs
all, part, and/or any combination of the duties listed below.
Perform in-depth medical assessment of key study information
through review of the protocol, Investigator Brochure, Informed
Consent Form, and appropriate literature Provide medical input for
protocol design, as appropriate ??Participate in Site Initiation
Visits and/or Investigator Meetings ??Provide 24/7 medical
consultancy support to investigators and study team ??Prepare
and/or review the Medical Monitoring Plan, as well as the Safety
Management Plan and related study documents ??Support for the
clinical team for subject selection regarding interpretation and
application of the protocol inclusion and exclusion criteria
??Follow study status via email, phone calls, and participation in
team meetings ??Participate in safety review meetings per protocol
??Perform review of Serious Adverse Events (SAE) reported by sites
to assess medical contents and case completeness, event
seriousness, expectedness, causality and identify potential safety
signals at single case level. Collaborate with site staff, Lotus
team members and sponsor staff to finalize each event. Develop
and/or SAE narratives and MedWatch reports ?Review protocol
deviations and classify according to agreed criteria Provide
support for the clinical team regarding early discontinuation of
treatment and end of study (EOS) assessments Provide review of
adverse events, concomitant medications and medical history to
assess overall risks to subject safety in addition to coding of
these data according to relevant dictionaries (MedRA/WhoDrug)
??Provide Medical review of other study data such as laboratory
results, ECGs, etc. per the scope of work ??Provide review and
comment on the Clinical Study Report (CSR) regarding overall study
conduct, protocol deviations, representation of adverse events and
other safety data, and general conclusions regarding safety and
tolerability and assessment of the objectives. Qualifications: To
perform this job successfully, an individual must be able to
perform each essential duty satisfactorily. ?? Must have a medical
degree-Psychiatrist (MD, DO or international equivalent). Current,
active medical license is preferred but not required. ??Prior
clinical research experience as a medical monitor, investigator,
safety physician or other applicable experience in clinical trial
conduct. A minimum of 5 years of relevant experience is required.
Clinical knowledge of the therapeutic patient populations and drug
class Knowledge and experience working with MedDRA and WHO Drug
medical dictionaries. Broad knowledge of ICH/GCP Excellent verbal
and written communication skills Ability to work in a fast-paced
team environment Experience: Excellent organizational and advanced
reasoning skills. Strong written and verbal communication skills.
Exceptional attention to detail. Strong interpersonal skills.
Strong computer skills, including ability to effectively utilize
common Microsoft Office products such as Outlook, MS Word and
Excel.
Keywords: Evolution Research Group, New Brunswick , CRO-PT Contract Medical Monitor, Psychiatrist, Science, Research & Development , New Providence, New Jersey
