Site Manager Job Description
CCT Research is growing tremendously! We are adding a Site Manager to our Omaha team to join us in our Mission: Leading today's trials, offering tomorrow's hope. And help make progress toward our Vision: For future generations to live in a world free of disease.
As a Site Manager, you will play a key role in assisting in clinical trial activities in accordance with all applicable regulations governing the conduct of clinical trials. You'll be working closely with study team members to achieve study objectives and contribute to corporate goals.
You are self-driven with a "can-do" attitude, team-building skills, adapt quickly and thrive independently, effectively communicate across multiple departments, and be thorough with details. You'll be working closely with study team members to achieve study objectives and contribute to corporate goals.
- Oversee the conduct of your assigned site; responsible for the training of staff/providers, process development, point of contact for the Directors of Operations and cross-functional teams.
- Work closely with Business Development and Feasibility on study placements.
- Accountable for enrollment success at sites across all studies; understand revenue expectations.
- Develop and implement patient recruitment strategies; actively recruit to achieve enrollment targets.
- Maintain a significant depth of knowledge and experience in coordinating across multiple therapeutic areas.
- Coordinate as primary CRC on at least six studies of medium to high complexity and back-up CRC on other studies when needed.
- Conduct 1:1 meetings and annual reviews with site staff.
- Assist in the development of the annual site roadmap.
- Complete all protocol-related training.
- Perform quality control checks on source documentation and regulatory.
- Work closely with the Quality Assurance Department to ensure quality at the site; create processes and CAPAs to improve trends.
- Perform patient/research participant scheduling.
- Collect patient/research participant history.
- Collect and maintains source documentation.
- Data entry and query resolution
- Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, nonclinical supply materials, imaging, laboratory handling manuals, etc.).
- Adhere to an IRB approved protocol
- Obtain informed consent of research subjects
- Support the safety of research subjects, report adverse events.
- Coordinate protocol related research procedures, study visits, and follow-up
- Facilitate site qualification, study initiation, and monitoring visits, and study close-out activities
- Ensure the proper collection, processing, and shipping of laboratory specimens
- Attend training(s) on leadership, communication, and other topics to help in the management of teams, as required
- Occasional participation in special project responsibilities and travel to other CCT locations when needs arise
- Comply with CCT, Clinic, and Sponsor policies, standard operating procedures (SOPs), and guidelines
- Fulfill responsibilities of CRC Level II
- Extensive knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Superior knowledge and experience of site operations and the drug development process
- Trained in leadership, project management, and process development
- Excellent written and verbal communication skills. Must be comfortable and effective in communicating with potential study participants from a diverse population.
- Interpersonal skills - open to others' ideas and willing to learn new things; respond well to questions and challenges.
- Reliable in word and action; punctual, trustworthy, and a consistent work ethic
- Process improvement – supports ideas and theories on process improvement for efficiency and effectiveness.
- Proficiency in Microsoft Word, Excel
- Contribute to essential medical research to make a positive impact in the future of healthcare. The work you do now can help many people live healthier lives in the future.
- Grow with us! Be part of a growing company with a culture of growth and support that encourages promotion within.
- We offer competitive pay and benefits.
Does this sound like you? Apply today, and we will get back to you quickly for an interview!
About CCT Research
CCT Research is a clinical site network with skilled physicians and staff who collaborate with pharmaceutical companies, with the goal of providing new and improved treatment options in the field of medicine. Patients participating in clinical research trials are provided in-depth medical care, given an opportunity to receive the newest treatment options at low to no cost, as well as giving hope to future generations.