Clinical Research Coordinator -244778 Job at Medix™, Modesto, CA

a3QvUGYxNnZ1OC9LZGtLVENDWXc0YVNrMGc9PQ==
  • Medix™
  • Modesto, CA

Job Description

**Seeking a Clinical Research Coordinator in Modesto, CA**

The research coordinator is primarily responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.

We seek a full-time clinical research coordinator to support our clinical research department. Although you must be able to work independently, you will be working directly with physicians, patients, research coordinators, clinical and business office staff and with pharmaceutical sponsor representatives to correctly and efficiently execute clinical research protocols. Collaboration and being a team player are essential to the success of this role.

As our clinical research coordinator, you will assist in the planning, development and implementation of clinical research trials.

Responsibilities:

  • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
  • Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on hand
  • Ensures study staff is properly trained on study-related information (i.e. protocol, ICF, manuals, etc.) and that the training is documented
  • Creates, manages, and maintains source documents for each trial
  • Attends teleconferences and Investigator Meetings as requested by research director
  • Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections
  • Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals
  • Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility accurately
  • Efficiently completes all study tasks delegated to them (i.e. scribing, VFQ, IOP, etc.)
  • Conducts and/or participates in the informed consent process/discussion with research participants, including answering any questions related to the study
  • Assures that amended consent forms are appropriately implemented and signed
  • Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately
  • Collects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified timeframe indicated in the study contract.
  • Oversees data and ensures that it is being entered correctly and resolves any queries issued within required timeframe
  • Collects and reports ALL Adverse Events
  • Collects and reports ALL Serious Adverse Events
  • Responsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewed
  • Coordinates monitor site visits and assists with preparation of site visit documentation
  • Works with the monitor to make any corrections needed to meet requirements and deadlines as needed
  • Collects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within required timeframe
  • Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor.

Job Tags

Full time, Contract work, Private practice, Work at office, Local area,

Similar Jobs

Beast Mode Truckin

Class A Local Or Regional Truck Driver - New CDL Graduates OK Job at Beast Mode Truckin

 ...We invite Class A Drivers, both new and experienced, to apply for our Dedicated account driving...  ...trailers across the Central and Western regions. Enjoy either daily home time or weekly...  ...0 miles of Harrisonville, MO (slip seat trucks) ~ The driver must be willing to drive... 

Broward County Public Schools

INTERN SCHOOL PSYCHOLOGIST Job at Broward County Public Schools

 ...POSITION GOAL To provide psychological services to students and to assist school personnel in designing and planning appropriate educational programs to facilitate the learning and overall adjustment of students. ESSENTIAL PERFORMANCE RESPONSIBILITIES... 

Snaphunt

Virtual Assistant Job at Snaphunt

 ...solid track record of success Flexible working options Opportunity to make a positive...  ..., and scheduling tasks for the team Assist with data entry, file management, and content...  ...For: ~12 years of experience as a Virtual Assistant or similar role ~ Excellent communication... 

Elite WorkForce Inc

Mail Room Office Clerk at FL Job at Elite WorkForce Inc

 ...Position: Mail Room Office Clerk Location: Tallahassee, FL 32399 Client: State of Florida Duration: 12+ Months Job Description: We are seeking a dedicated Mail Room Office Clerk to manage daily mail operations, including sorting and processing outgoing... 

United Parcel Service

Package Handler - Hiring ASAP Job at United Parcel Service

Package Handler - Hiring ASAP at United Parcel Service summary: Seasonal Package Handlers at UPS are responsible for loading and unloading packages from trucks in a fast-paced warehouse environment. The role requires physical stamina, the ability to lift heavy packages...