Clinical Research Coordinator

Clinical Research Coordinator - Worcester, MA (01701)

Hours: Monday - Friday, normal business hours

Format: contract-to-hire, 6 months

Pay: $32.69 - $33.65/hour

Responsibilities:

Adhere to clinical trial protocols and coordinate and perform assigned clinical trial activities including, but not limited to:

• Participant pre-screening, recruitment and scheduling
• Complete protocol and trial system training
• Maintenance of regulatory documents
• Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study.
• Conducting participant visits
• Entering data in the EDC and resolving all queries
• Updating and maintaining trial logs and participant charts
• Conducting monitoring visits and resolving issues as needed in a timely manner
• Managing and reporting of AEs, SAEs, and deviations
• Maintains adequate inventory of study supplies
• Coordinates appropriate and timely payments to participants
• 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
• Communicate effectively and professionally with coworkers, leadership, trial participants, sponsors, CROs, and vendors.
• Apply good documentation practices in accordance with ALCOA-C standards when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Track screening and enrollment status of patients in site systems and ensure timely communication with patients regarding their study participation
• Understand thoroughly all assigned studies through reading protocols an completing assigned trainings, including preparing for attending site initiation visits (SIV's) and Investigator Meetings (IMs), as needed
• May set up, train and maintain all technology needed for studies
• Adheres to and supports all Federal regulations and company policies and procedures instituted to safeguard protected health information (PHI)
• Perform other duties as assigned

Required Skills:

• Phlebotomy experience
• 2 to 3 years within clinical research

Preferred Skills:

• College degree (health sciences) preferred or significant relevant experience
• At least 2 years of CRC experience in a direct patient care role
• Knowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trials
• Fluent in written and spoken English

For California Applicants:

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.

Here at Medix, we are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest growing companies by Inc. Magazine.

Our commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our co-workers! The goal is lofty, but it is made attainable through the hard work and dedication of our teams and their willingness to lock arms together. Are you ready to lock arms with us?