Contract Analyst - Exempt

Informed Consent Specialist

Open to market dictated BRs HM's Top Needs:

1. Experience related to the management and negotiation of the Patient Informed Consent, specifically within the US

2. Document management and ability to follow standard operating procedures and appropriate document management (ensuring key stakeholders are engaged, documents are uploaded to the trial master file, all while ensuring quality of the content)

3. Relationship management and ability to work with diverse teams (study team, functional team, site research team)

Education Required: Bachelor's degree, ideally in Clinical Research, Biology or Chemistry, and a

Years' Experience Required: minimum of 2 years of experience working on consent/Informed Consent (IC)/contracts within clinical research, or advanced degree in Clinical Research, Biology or Chemistry with 0 years of experience.

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes

Work Location: Remote- at FTC home office

Do they need to be local to any MDT office and if so where? No

Does this person need to be on site? If so, full time or part time? No

The Informed Consent Specialist (ICS) serves as the primary point of contact for our client study teams and external research centers for informed consent (IC) template development and IC related activities during Institutional Review Board/Ethics Committee (IRB/EC) approvals and renewals. The ICS will develop strong working relationships with research centers and a familiarity with study participant matter in order to accelerate research center initiation cycle times and foster strong partnerships. The ICS will partner with other internal our client functions such as field clinical personnel, contract analysts, study team members, monitors and legal departments to accomplish these goals.

Informed Consent Management:

• Act as primary contact for assigned clinical studies and associated clinical sites for all activities related to ICs;
• Coordinate activities of internal and external stakeholders to assure the timely, accurate and regulatorily compliant completion of the IC approval process;
• Lead IC development with clinical sites, field personnel and study teams;
• Customize ICs based on clinical site and IRB/EC/REB specifics learned from collaboration during prior studies;
• Provide appropriately organized documents to internal MDT stakeholders to ensure accurate and timely IC review;
• Collaborate with Contracts function to ensure alignment between clinical trial agreements (CTA) and their associated IC;
• Act as single point of contact ("Lead ICS") for all IC-related questions from study teams of assigned studies, including attendance at study team leadership meetings and providing study status updates;
• Attend investigator/coordinator meetings as needed--train on research center initiation practices;

Document Management:

• Create and maintain accurate IC files; ensure receipt and storage of proper documentation; ensure proper legal, study team, and IRB/EC approvals and storage thereof;
• Document key IRB/EC and center specific learnings;
• Identify and actively resolve issues related to IC documents;
• Perform periodic audits of IC files for completeness and actively drive completion of action items;
• Accurately update and maintain internal tracking systems (online clinical trial management system);

Relationship Management:

• Partner with other internal our client functions (e.g. contract analysts, study team members, field personnel, legal, monitoring, etc.) to meet or exceed customer expectations;
• Develop a thorough understanding of assigned research centers' and studies' processes and practices;
• Demonstrate ability to foster strong partnerships with assigned research centers' coordinators and other research center personnel, as needed; and,
• Actively train and mentor ICSs within team,
• Initiate and support development of process improvement initiatives; and,
• Utilize applicable SOPs, policies and practices for guidance. Communicate with senior leadership on SOP interpretation and provides SOP guidance to other MDT employees.

Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume.

• Bachelor's degree, ideally in Clinical Research, Biology or Chemistry, and a minimum of 2 years of experience working on consent/Informed Consent (IC)/contracts within clinical research, or advanced degree in Clinical Research, Biology or Chemistry with 0 years of experience.

Nice to Have (Preferred Qualifications):

• 3-5 years clinical study administration or related experience;
• Juris Doctor/law degree or advanced degree in Clinical Administration;
• Bilingual (or more);
• Previous experience at our client;
• Demonstrated expertise in medical or technical area;
• Complete understanding of clinical processes, regulations and regulatory standards; and,
• Proficiency with regulatory and compliance guidelines for clinical trials.