Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures. May serve in Lead CRA role
2. Regulatory Documentation
- Maintains timely and effective communication among team members and site staff.
- Keeps project leadership apprised of team issues, seeking guidance as needed.
- Participates in Business Development client presentations and bid defenses as requested.
- Assures compliance with CFR, State regulations, ICH and GCP guidelines and INC Research and sponsor SOPs.
- Maintains current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
- Participates in TMF and on-site audits as requested.
4. Data Handling
- Assumes responsibility for site management and site staff performance including,
- Monitors all types of clinical trials.
- Participates in all types of site visits.
- Assures Principal Investigator (PI) integrity.
- Assures compliance with all protocol requirements.
- Assures effective patient identification and recruitment plan is in place.
- Assures timely reporting of AEs/ SAEs and Protocol Violations.
- Regularly perform Investigational Product (IP) accountability.
- Regularly review the status of contents of the site Regulatory Binder.
- Performs training visits with less experienced CRAs.
- Participates with assessment of less experienced CRAs for the sign off visits after approval by manager and completion of required training.
5. Reporting and Tracking
- Performs source document verification (SDV) according to contractual requirements.
- Assures timely completion and submission of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
- Assures timely and accurate completion of Data Clarification Forms (DCFs).
- Performs clinical data listings reviews as needed.
- Completes and submits visit trip reports according to SOP requirements and requiring minimal revisions.
- Maintains awareness of key study performance indicators for own sites, e.g. patient enrollment, SAEs.
- Updates study and patient status information and serves as (CTMS) resource for PM/LCRA.
- Tracks Investigator payments/ milestones, if requested.
- Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
- Assists with preparation and attends investigator’s meetings as requested. May present as requested.
- Assists with the preparation of study start up materials and tools, as requested.
- Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project Communication, Monitoring and / or Training Plans.
- May assume Clinical Team Lead/ Lead CRA role and/ or assist with LCRA activities, e.g., tool development, study plans, team training.
Performs other work related duties as assigned. Demonstrates extensive understanding of SOPs, WI, FDA and local regulations as well as ICH guidelines. Extensive travel may be required (more than 50%).
Skills & Attributes
Requires a BA/BS degree in the science/health care field, nursing degree, or equivalent combined education and experience plus moderate clinical or related research experience with some of independent field monitoring experience or equivalent. ACRP certification is strongly encouraged and preferred. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email, and voicemail are required. Must have valid, current driver’s license and ability to secure corporate credit card.
For employees in the United States ONLY
FLSA status: ____Exempt_____________________________________________
Years of experience required: __Three (3) years ____________________________
Physical Requirements: Position requires: ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. The noise level in the work environment is low.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.
Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
INC Research is an EEO, M/F/D/V and a drug-free workplace. INC Research voluntarily participates in the federal E-Verify work authorization program.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to firstname.lastname@example.org . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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INC Research - 2 years ago
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INC Research is not fazed by the four phases a new drug has to go through to get from idea stage to commericial adoption. The contract...