Clinical Research Coordinator

Mid Atlantic Retina; Bethlehem (Northampton County); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

401(k) & Profit Sharing

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short & Long Term Disability

Paid Time Off

Bonuses

Job summary

Mid Atlantic Retina is seeking a Research Coordinator to manage a broad scope of clinical trials from phase 1 through phase 4. You will coordinate patient enrollment, consent, data collection, and regulatory compliance while collaborating with physicians and staff.

The role emphasizes patient interaction, meticulous documentation, and timely communication with sponsors and CROs to drive successful outcomes in a fast-paced ophthalmology research environment.

Qualifications

• College degree in related health science or 2 years Clinical Research work experience.
• Desire to work with patients.

Responsibilities

• Coordinate all aspects of Mid Atlantic Retina's phase 1 through phase 4 clinical trials.
• Obtain written informed consent and ensure proper documentation.
• Maintain awareness of regulatory needs and ensure action items are completed.
• Enroll and retain patients within protocol parameters and ensure data integrity.
• Communicate proactively with sponsors and CROs to ensure timely study items.

Skills

Patient interaction

Education

College degree or clinical research experience

Job description

This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires.

Job Type: Full Time

Sign on bonus Eligible: Yes

Training: Full Orientation in addition to ongoing department training and study training.

Qualifications

• College degree in related health science or 2 years Clinical Research work experience.
• Desire to work with patients

Full Job Description

Mid Atlantic Retina is one of the largest retina practices in the area, offering bonuses, top pay and growth opportunities for employees to not just work a job, but build a career. As a Research Coordinator, you will be responsible for coordinating all aspects of Mid Atlantic Retina's phase 1 through phase 4 clinical research trials.

Benefits

• 401(k) & Profit Sharing
• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short & Long Term Disability
• Paid Time Off
• Bonuses

Essential Functions

1. Maintains a solid understanding of objective (primary and secondary endpoint) and rational of study.
2. Obtains written informed consent and ensures all documentation of processes.
3. Maintains awareness of regulatory need for study and ensures completion of action items.
4. Reviews 1572 and delegation logs prior to start of study.
5. Provides guidance to ancillary staff (Photographer, OCT Tech, BCVA, Receptionist, unmasked personnel) to make sure protocol is properly completed and any action items are completed. Communicates with them proactively throughout the study.
6. Understands inclusion and exclusion criteria as they relate to study objectives, patient safety and retention of patients for valuable data.
7. Informs subjects of any study changes including risks and signs amended informed consents.
8. Collaborates with Screening Department in order to initiate a screening packet within the time frame for enrollment.
9. Determines required visits and protocol agendas.
10. Enrolls and retains patients in all assigned clinical trials.
11. Manages clients within protocol parameters to ensure patient safety and the collection of valuable data and keeping protocol violations to a minimum.
12. Completes clear, concise documentation of source documents following sample source SOPs to compliment data in CRFs in a timely manner.
13. Records all communication in source or regulatory file.
14. Communicates proactively with sponsors and CROs and assures all action items are completed in a timely manner.
15. Boosts enrollment by informing doctors of study details, competing chart reviews and utilizing supplemental material.
16. Responds to referrals within 24 hours.
17. Completes all DCFs and ECRFs in a timely manner (within 7 days of visit).
18. Works with CRAs, Medical Monitors and/or other personnel who are instrumental in answering questions, as well as building a professional rapport that can help in the successful undertaking and completion of study.
19. Transports clinical specimens to lab or arranges for specimen pick up.
20. Follows all FDA/GCP regulations.
21. Responsible for all regulations for assigned clinical trials.
22. Cross-covers for other Coordinators as needed.
23. Telephone screening of patients.
24. Regular and predictable attendance required.
25. Works overtime as needed.
26. Travels as needed.
27. Performs other duties as assigned.

Physical & Cognitive Demands

1. This position is very active and requires standing and walking all day in order to get patients and bring them to rooms, assist physicians and rotate assignments with other staff.
2. While performing the duties of this job, the employee is regularly required to talk, communicate verbally in front of groups, one to one and over the telephone and in email.
3. Occasional bending, kneeling, stooping, and crouching.
4. Lift or move objects weighing over 15 pounds as needed.
5. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Working environment in exam rooms is often in moderate light.
6. Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina.
7. Ability to raise dominant arm above shoulder height to administer drops.
8. Use senses to observe and examine patients, paying attention to detail.
9. Works with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying and recording, storing and retrieving information.
10. Sustain physical contact with another person in order to guide them due to their diminished vision.