Position Summary: This position supports the mission of Presbyterian/St Luke's Medical Center of optimizing the quality of life of all those served by expanding beyond the traditional focus on medical needs to the needs of the whole person. The Research Assistant provides support to the CBCI Clinical Research Team on a daily basis, ensures all activities are conducted according to company SOPs, and all application GCP and ICH regulations and guidelines
Under the direction of the Research Supervisor, job duties include:
Supports CBCI Research Team to meet industry/ investigator initiated trial data deadlines
Obtain source documentation for patients enrolled into clinical trial
Assist CBCI Research Team with case report form completion
Assist CBCI Research Team with query resolution
Assist in AE/SAE reporting and tracking
Create and maintain patient visit tracking spreadsheets for CBCI Research Team
Maintains and archives study administrative files
Maintains assigned closed to accrual trials
Collects, completes and enters data into study-specific case report forms or electronic data capture systems
Maintain and manage monitor visit calendar
Participates in monitor visits for each assigned trial at each monitoring visit.
Reviews and comment on follow up monitor letters
Reviews source documentation and queries for missing documentation.
Maintains case report forms tracking management database.
Reviews trial data for clinical relevance and answers appropriate queries.
Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations.
Archives study documentation and correspondence per company policy.
Process all required study laboratory samples following
Process and ship pharmacokinetic/pharmacodynamic and all other samples according to instructions provided by study sponsor
Prepare study supplies/source documents necessary for obtaining lab samples prior to patient treatment
Maintain accurate records of sample acquisition and shipping.
Ensure lab kits and other supplies for all active studies are adequate, all supplies are in date and lab kit inventory is maintained and kept current. Ensure all supplies are clearly labeled for study
Unpack all supplies delivered daily
Schedule appropriate courier for sample shipments. If too late for courier, be available to make arrangements to drop samples at FedEx, UPS, etc. if necessary
Ensure there is an adequate supply of dry ice available for shipments
Ability to respond to queries generated from study sponsor or contract lab regarding patient/sample data
Check and respond to emails daily
Maintain laboratory equipment and workspace in all areas
Package and ship research samples per IATA guidelines
Maintains a document management system for regulatory paper and electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP's) for format and content.
Maintains updated physician credentials for study participation and other critical documentation ensuring compliance.
Modify and/or develop informed consent forms and updates and manages protocol and consent form modifications or amendments in compliance with IRB policy and HIPAA.
Organizes and coordinates IRB documentation for trials.
Assist any internal or external audit team with any regulatory related issues.
Apprises research supervisor, of all study and site-specific regulatory issues for guidance and follow through.
Archives study specific regulatory documentation and correspondence.
Provide required metrics to leadership as requested
Meets with clinical study sponsor representatives as requested.
Attends meetings as assigned and reports on actions.
Participates in educational activities and programs.
Maintains strictest confidentiality.
Works closely and effectively with all other department personnel.
Assists other staff as requested and performs other related work as needed.
Throughout the clinical trial adherence to CBCI and PSL SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines.
Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement".
During your employment with CBCI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
Other duties as assigned by manager.
Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital for Children expects our Code of Conduct Value Statements to be reflected in the way every employee interacts with co-workers, patients and family members, and with others in the community.
We recognize and affirm the unique and intrinsic worth of each individual
We treat all those we serve with compassion and kindness
We act with absolute honesty, integrity and fairness in the way we conduct our business and the way we live our lives.
We trust our colleagues as valuable members of our healthcare team and pledge to treat one another with loyalty, respect and dignity
A. Licensure/Certification/Registration: Medical Assistant certification preferred.
B. Education: Associates Degree or combination of equivalent education and experience preferred.
C. Experience: 2 years healthcare experience preferred. 1 year clinical trials support or health related experience preferred.
D. Special Qualifications: The Research Assistant requires the ability to operate a computer, needs to have medical terminology and clerical perception. Must maintain a high standard of communication skills, and must maintain constructive interpersonal skills. Needs to be highly organized. Basic knowledge of Microsoft Word and Excel required.
Degree of supervision required: Involves general guidance and direction by the Research Supervisor. Employee will be expected to perform most job duties independently and in accordance with established departmental and hospital policies and procedures.
Ages of Patients Served: This position requires knowledge of growth and developmental needs of patients and families. Personnel in this position must recognize and respond to the behaviors of patients and families in each age category. The employee must be able to demonstrate the special skills required to care for patients and their families according to standards. (The skills and knowledge needed to provide such care may be gained through education, training or experience.)
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