Coordinating all aspects of patient involvement from study initiation until study completion;
Study start-up:
o assist in the creation of thorough and accurate source documents;
o Work collaboratively with other internal departments, sponsors and investigators to ensure protocols are understood and assist in the trainings of staff members
o Participate in IMs and SIVs; communicating with sponsors and representatives
o Ensure site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)
o Screening participants for actively enrolling studies
o Assist in reviewing all participant history from Pre-Enrollment and Enrollment departments confirming information with potential participant and study physician
o Educating potential participants and caregivers on protocol specific details and expectations;
o Working with the physician to address all questions and concerns related to the trial and informed consent process;
o Maintaining thorough knowledge of study specific inclusion/exclusion criteria
o Coordinating scheduled visits and adhering to protocol visit windows and timelines
o Perform or follow up on safety and efficacy assessments per protocol vital signs, EKGs, blood draws and other assessments as assigned
o Collaborating with the research pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimen
o Accurate and timely completion of source documents recording subject’s participation in study
o Communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines
o Assist investigators in collection of information from study subjects regarding AEs, concomitant medications and other changes throughout participation
o Responsible for subject scheduling, in coordination with Recruiting
o Responsible for timely data entry and query resolution
o Timely reporting of study events (SAEs, protocol deviations, etc) to appropriate departments and other outside agencies (Sponsors, CRO’s, etc.)
o Following subjects through study completion and creating follow-up care plan with physician, study subject and primary care provider;
Ensuring preparation for and facilitating of all study monitoring visits and following up promptly with monitor follow-up letters
Prompt and professional communication with sponsors, representatives and other study related parties
Maintaining professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members
Keeping management informed of study status and any study-related issues
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.
EDUCATION/EXPERIENCE/SKILLS
Bachelor's Degree or equivalent experience in Clinical Research or related field.
Demonstrated expertise in:
o knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials
o providing strong leadership and mentorship to others
o developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level
o crisis management and problem solving; ability to react calmly and effectively in emergent situations
o working independently as well as functioning as part of a team
o communicating clearly both written and verbally
Highly proficient in:
o In the use of technology required for the completion of study visits and study conduct
o completing paperwork with precision, accuracy, and attention to detail
o meeting timelines and attention to detail
o prioritizing daily tasks with minimal guidance
o using medical equipment and instruments to administer study subject care
o medical terminology
Must be able to effectively communicate verbally and in writing.
WORKING CONDITIONSIndoor, office environment.
Essential physical requirements include sitting, typing, standing, and walking.
Lightly active position, occasional lifting of up to 20 pounds.
Reporting to work, as scheduled, is essential.
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
