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Temporary

Clinical Research Coordinator

Competitive

Framingham, MAScience & PharmaceuticalPosted 21d ago

You'll complete your application on the employer's website.

Role overview

Job type

Temporary

Salary

Competitive

Posted

21 days ago

Job description

Medix is recruiting a Clinical Research Coordinator for an unidentified client. The role coordinates and performs clinical trial activities, including participant visits, regulatory documentation, data entry, and study compliance.

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

Preferred

College degree (health sciences) preferred

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

Health Sciences Degree

Relevant Experience

Clinical Research Coordinator Experience

Direct Patient Care

Clinical Practice (GCP)

IATA Regulations

FDA Clinical Trial Regulations

Written English Fluency

Spoken English Fluency

Company

Medication and health product distribution in Lebanon.

Jdeïdé, Mont-Liban, LBN

https://medixdistribution.com/

Founded in 2007

11-50 employees

Qualifications

Phlebotomy experience

2 to 3 years within clinical research

College degree (health sciences) preferred

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

Required skills

Represents the skills you have, click on the tags, Phlebotomy, IATA Regulations, FDA Clinical Trial Regulations, Direct Patient Care

Preferred skills

College degree (health sciences) preferred, significant relevant experience, Fluent in written and spoken English, Glassdoor, 4.1, Jdeïdé, Mont-Liban, LBN, https://medixdistribution.com/, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

2-3 years

Interested in this role?

Apply directly on the employer's website — it only takes a few minutes.

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