Job Descriptions
Clinical Study Manager
Seeking a full-time Clinical Study Manager. TopLine conducts studies (Phase 2 through 4) across various therapeutic areas. We consider it an honor and professional privilege to get to work in the clinical trial/drug development space. We’re passionate about the life-long career opportunities this space offers to individuals. We are a stable, healthy, enthusiastic, and fun team of researchers looking for someone with these same qualities who is interested in growing within the company.
Qualifications and responsibilities:
A MINIMUM of three years of clinical research experience
BA/BS degree
An excellent ability to review a clinical trial protocol and “see” the operational aspects in a meaningful way, with the ability to quickly identify areas of ambiguity or specific challenges
An excellent knowledge base for clinical research processes at the site level, including but not limited to regulatory documentation, working with IRBs, patient recruitment
Ability to interact with sensitivity, confidence, and professionalism with patients, families, and medical teams
Travel to, attend, and actively participate in Investigator Meetings for assigned studies
Perform study-specific assessments, including administration of PROs, phlebotomy, specimen processing and shipments, as required by the protocol
Prepare study documentation (source documentation, regulatory documents, etc.) for CRAs, in advance of QVs, SIVs, IMVs, and COVs
Track and report overall performance on screening, enrollment, and study completion for assigned trials
Engage with community partners to raise awareness for open studies, including hosting booths at local health fairs and community events,
as appropriateAccurately record/maintain source documentation and enter data into clinical databases with high attention to detail
Identify and report protocol deviations, based on protocol requirements
Complete all training required per protocol and per Company policies (including IBs, protocols, system training, SOPs, etc.)
Excellent handwriting, and overall appreciation for ALCOA+ principles
Excellent communication skills and positive interpersonal skills
Flexible, energetic, and adaptable attitude
Attention to detail, with complete and thorough follow-up of assigned tasks
Ability to work independently, without close supervision
Ability to oversee junior team members, with a spirit to teach, train, invest
The following qualifications are preferred:
ACRP certification
Phlebotomy skills
Experience in EDC systems
The person we hire will be someone who wants stability and longevity in a job and will be invested in supporting the growth of our clinic and an integral part of our team.
Principal Investigator
This position will ensure the quality and scientific integrity of the studies performed in the site, safety of the participants, quality of the medical data collected during the studies, and respect the medical and ethical requisites and GCPs.
The Principal Investigator will be involved in all steps of clinical research studies and work with all team members to perform required procedures of studies conducted on behalf of sponsors.
This is a part-time/PRN position. Both experienced PIs and recent graduates with state licenses are encouraged to apply.
Responsibilities:
Act as the Principal Investigator on assigned trials, ensuring appropriate involvement in all aspects of study conduct at the site
Travel to, attend, and actively participate in Investigator Meetings, when necessary
Collaborate with the study team to oversee the conduct of the study
Ensure medical follow up during the study (inclusion/exclusion criteria verification, adverse events, laboratory data monitoring and validation, ECG, etc.)
Validate the inclusion/exclusion criteria to ensure full eligibility of patients prior to enrollment in a study.
Perform physical examinations required by the protocol, administer the study drug, manage the medical events and particularly the adverse events and concomitant medications, and validate end of study visits
Perform study-specific assessments, as required by the protocol, where such procedures require completion only by the PI or sub-I
Review and acknowledge medical parameters (safety labs, ECG, BP, etc.) measured during the study according to the protocol
Complete all training required per protocol and per Company policies (including IBs, protocols, system training, SOPs, etc.)
Review and sign CRF for each study participant, based on database lock milestones on assigned studies
In case of a significant AE during a study, oversee the appropriate notifications and documentation to the sponsor
Ensure good practical progress of the study, from a medical point of view, and report and document any deviations from the protocol
Communicate directly with the sponsor’s (or CRO’s) medical monitor to resolve medical questions regarding a study protocol, with strong documentation of those discussions
Remain available at all times in case of medical issues with study participants
Answer medical questions raised during monitoring visits
Qualifications:
Current Texas License as a MD or DO
Board Certification
