Job Overview
This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, 2can-do2 attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. The employee, working closely with study team members, will achieve study objectives and corporate goals.
Essential Functions
Oversees the conduct of their assigned site; responsible for the training of staff/providers, process development, point of contact for the Directors of Operations and cross-functional teams
Works closely with Business Development and Feasibility on study placement
Accountable for enrollment success at sites across all studies; works to understand revenue expectations
Develops and implements patient recruitment strategies; actively recruits to ensure enrollment targets are achieved
Maintains significant depth of knowledge and experience in coordinating across multiple therapeutic areas
Ability to coordinate as primary CRC on at least 6 studies of medium to high complexity, as well as back-up CRC on other studies when needed
Conducts 1:1 meetings and annual reviews with site staff
Assists in the development of the annual site roadmap
Completes all protocol related training
Performs quality control checks on source documentation and regulatory
Works closely with Quality Assurance Department to ensure quality at site; creates processes and CAPAs to improve trends
Performs patient/research participant scheduling
Collects patient/research participant history
Collects and maintains source documentation
Performs data entry and query resolution
Supports the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging and laboratory handling manuals, etc.).
Adheres to an IRB approved protocol
Obtains informed consent of research subjects
Supports the safety of research subjects, report adverse events.
Coordinates protocol related research procedures, study visits, and follow-up
Facilitates site qualification, study initiation, and monitoring visits, and study close-out activities
Ensures proper collection, processing, and shipping of laboratory specimens
Attends training(s) on leadership, communication, and other topics to help in the management of teams, as required
May be asked to perform special project responsibilities and travel to other CCT locations when needs arise
Complies with IQVIA, CCT, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
Performs other duties as assigned
Qualifications
Must have clinical skills experience with patients to obtain vitals and perform procedures such as blood draws, EKG, etc.
Must demonstrate the ability to fulfill responsibilities of CRC Level II
Extensive knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Superior knowledge and experienceof site operations and the drug development process
Trained in leadership, project management and process development
The potential base pay range for this role, when annualized, is $64,600.00 - $161,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
