SYNOPSIS:
The Clinical Research Coordinator (CRC) will play a vital role in managing and executing clinical trials. Responsibilities include developing a deep understanding of study protocols, conducting informed consent processes, and strategizing with management on recruitment, enrollment, and retention of participants. The CRC will oversee data collection, track enrollment milestones, and communicate with CROs and sponsors, ensuring compliance with regulatory standards. Additionally, the CRC will adhere to all protocol-related activities, including federal and state regulations, as well as the policies and procedures of The Retina Partners and affiliated facilities.
Key qualifications include a bachelor’s degree in a related field, previous experience in clinical research, and knowledge of Good Clinical Practice (GCP). Strong organizational and communication skills are essential, along with proficiency in data management software
EDUCATION & EXPERIENCE:
- Bachelor's or Master’s degree in Biology, Research, or related field OR
- Minimum 1-2 years of experience in Clinical Research
REQUIREMENTS & QUALIFICATIONS:
- Knowledge of Good Clinical Practice (GCP) and regulatory requirments
- Knowledge of FDA, OHRP, and NIH regulations and guidelines pertaining to the performance, documentation, and reporting of research.
- Strong organizational skills with the ability to manage multiple projects and deadlines.
- Excellent communication skills, both written and verbal, for effective interaction with participants, sponsors, and team members.
- Proficiency in data management software and Microsoft Office
- Attention to detail and a commitment to maintaining high standards of accuracy in documentation.
- Problem-solving skills and the ability to think critically in high-pressure situations.
- Ability to work independently as well as collaboratively within a team
Clinical Research Coordinator:
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
- Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Will screen or assist with screening subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Completes study documentation and maintains study files in accordance with sponsor requirements and the sites policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Retains all study records in accordance with sponsor requirements and institutional policies and procedures.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Other duties a CRC may have include serving as a liaison with other departments, maintaining regular communication with the sponsor, or IRB, assisting the investigator with budgeting and contracts, problem-solving, coordinating sponsor or regulatory audits, recruiting new studies, and professionally representing the site to all in the best possible light.
- Conduct in-person prescreening of potential trial participants
PHYSICAL STANDARDS:
Positions in this class are situated in a standard office environment where there is little or no exposure to variations in the weather or other similar elements. Physical agility must be such that the CRC is able to sit, walk, crouch, lift, and utilize phones for extended periods of time while utilizing their hands, wrists, legs, and arms. This position utilizes office machines (e.g., computers, adding machines, printers, copiers, scanners, etc.) and requires sufficient manual dexterity to operate them all. The CRC should be able to lift up to 20 pounds repeatedly and 45 pounds intermittently.
Job Type: Full-time
Pay: $21.00 - $28.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Education:
Experience:
- Site Level or Industry Level Clinical research: 1 year (Preferred)
Work Location: In person
