Clinical research coordinator job description

(40%) Study Set-up - Performs all aspects of the set up process to include the development and approval of study specific documents, study schedules and clinical procedure planning

(30%) Coordination - Coordinates the running of critical events, i.e. check in, PK days, check out by resolving/escalating issues identified by both staff and study participants. Monitors and maintains participant safety, dignity and compliance, including coordination of appropriate medical consultation/treatment as appropriate. Provides updates regarding study participants wellbeing to the investigators and Project Manager including adverse event updates

(20%) Study Meetings -Facilitates/attends and contributes to all key Study Planning meetings, i.e. Clinical Start Up Meeting, Clinical Planning Meeting, Site Initiation Meeting

(10%) Protocol Review - Reviews protocols, provides consolidated comments from the clinical site on the draft study protocol to the Project Manager or Medical Writer, taking into account the logistics, safety (staff and study participants), and site's capabilities. May distributes final protocols and amendments to the site

Study Planning - Proactively works with the site to ensure that the laboraratory, equipment and all operational requirements are fulfilled and that the study is adequately resourced. Working closely with the Operations and Pharmacy to ensure dosing runs efficiently and that all documentation is completed accurately within a timely manner

Complaints - handles participant complaints efficiently and effectively in order to maintain customer satisfaction.

Clients - Is aware of client expectations for trial conduct and works to meet or exceed them. Facilitates client visits, and attends client calls with the assistance of the Project Manager and/or site management where appropriate. Participates in Client and process Audits by covering study conduct questions.
Training - Deliver/facilitate study specific training Learns and develops Clinical skills to perform study tasks and performs procedures as necessary Participant eligibility - verifies eligibility for Panel Selection and at Pre dose by determing whether protocol criterion has been met. Communicates with investigators and PM regarding study participant eligibility Oversees maintenance of study master file ensuring that site related documents are available for uploading to the eTMF Create/manage study specific shipping calendar ensuring biological samples are shipped as directed by the client in a timely manner Data Monitoring - Facilitate/coordinate monitoring visits and coordinate site resolution of any comments/queries raised Quality - Ensures all protocol deviations and or unscheduled events are properly documented and communicated. Works with site management to maintain timely completion of issues raised from CQI's and client audits , implementing new processes where necessary Works with Recruitment/Screening to define a recruiting plan ensuring that the study is recruited on schedule, updating Project Manager on a regular basis Consult with pharmacy staff to ensure awareness of receipt inventory, accountability and disposal of clinical trial materials Assist with on time source document completion and query process Authorizes study participant stipend payments as required
Performs other related duties as assigned
Qualifications:
Typically a minimum 3-4 years' experience in a research environment Knowledge of protocol designs, study objectives and study procedures Knowledge of drug development process, ICH guidelines and GCP Previous customer service experience desirable Previous experience of coordinating people or processes desirable. University/college degree desirable (life science, pharmacy or related subject preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology). In lieu of a degree, typically 3 years' experience in a related field will be considered
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
For more information about how we collect and store your personal data, please see our Privacy Statement .

The Department of Molecular Virology & Microbiology is seeking an Assistant Coordinator, Clinical Research. The candidate will proactively identify and recruit from pediatric and adult populations for potential enrollment into vaccine, treatment, non-interventional, or other clinical research trials. This will be a full-time position with time split between the office setting and community engagement.
Identifies and establishes new contacts as recruitment resources in the community. Develops and/or implements creative and existing processes to increase the existing recruitment base. Advertises for research participants through development and distribution of flyers, pamphlets, social media, etc. Attends community and health events to identify potential study participants and invite them to participate in research projects. Makes presentations at places of business to aid recruiting efforts. Conducts phone pre-screenings of potential participants interested in clinical research studies. Schedules participants for enrollment and follow up visits and keeps study schedules current and updates study personnel with recruitment and schedule status. Maintains and updates a recruitment portfolio and database.



Minimum Qualifications



High School diploma or GED. No experience required.



Preferred Qualifications



Ability to understand basic medical terminology and eligibility requirements for clinical research studies and protocols. Experience with computer spreadsheets and database management. Excellent communication and organizational skills. Must provide own transportation for travel in the community with mileage reimbursement. Experience in a clinical research setting and/or public relations-related experience is preferred. Marketing/networking skills helpful. College degree is preferred. Bilingual-English/Spanish is helpful.


Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

13283

CA; SN

At Scripps Health, you will experience the pride, support, respect that has been repeatedly recognized as one of the nation's Top 100 Places to Work.

You'll be surrounded by people committed to making a difference in the lives of their patients and their teammates. So if you're open to change, go ahead and unlock your potential.

Housed within Scripps Health, Scripps Whittier Diabetes Institute (SWDI) is Southern California's leading diabetes center of excellence, committed to providing the best evidence-based diabetes screening, education and patient care across Scripps Hospitals and clinics, and in the surrounding community. Founded in 1981, SWDI's mission is to improve the quality of life for individuals with pre-diabetes, gestational diabetes, type 1 and type 2 diabetes through diverse programs, including diabetes self-management education, behavioral health, clinical research, diabetes prevention, retinal screenings, and professional training and education. SWDI's interdisciplinary team is comprised of endocrinologists, psychologists, nurse practitioners, registered nurses and dietitians, diabetes educators, and researchers. Our current portfolio of research projects is funded by the National Institutes of Health and non-federal sponsors, and evaluates a variety of pharmacological, device, behavioral, and psychological interventions to improve the quality of life for individuals living with diabetes.
Responsibilities of the Research Coordinator include:

* Functions as a liaison between the organization, investigators, and the research sponsors.
* Responsible for planning, implementation and oversight of a variety of clinical trials, maintains compliance with all applicable institutional, state and federal regulations in collaboration with investigator.
* Performs independently as a project manager to coordinate all aspects of clinical research projects including administrative functions and clinical functions per scope of practice.
* Other responsibilities include recruiting, retaining, motivating and educating research patients in clinical trials, training other research personnel in research procedures, oversees research finances and tracking patient enrollment.
* Works with other disciplines to execute trials, and acts as patient advocate to contribute to the overall research objectives of the program.

This is a permanent, full time, hourly position with varied shifts located on the campus of Scripps Memorial Hospital La Jolla.

*Required Education/Experience/Specialized Skills:*

* 2 years clinical trials or healthcare experience.
* Advanced written, oral and interpersonal communication skills.
* Strong prioritization, organizational, and problem solving skills.
* Strong motivator/communicator in a compact clinical team working with aggressive timelines.
* Strong computer skills with Microsoft Office software.

*Required Certification/Registration:*

* CCRP or CCRC required within 1 years of date of hire.
* BLS.

*Preferred Education/Experience/Specialized Skills/Certification:*

* BS or BA.
* 3 years clinical trials experience with an Associate's degree.
* 4 years clinical trials experience as Medical Assistant or Lab technician.
* Proficiency in medical terminology.
* LVN

**Job:** **Research*

**Organization:** **Scripps Health Corp*

**Title:** *Clinical Associate Research Coordinator - Scripps Whittier Diabetes Institute*

**Location:** *Central San Diego County-LA JOLLA-SCRIPPS WHITTIER DIABETES INSTITUTE*